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 and joined the MJH Life Sciences team in April 2021. He graduated from The College of New Jersey with a degree in Journalism and Professional Writing. He enjoys listening to records, going to concerts, and playing with his cat Squish. You can reach him at 

A new cross-sectional analysis linked work-related stress to an unfavorable impact on cardiovascular health (CVH) among a multi-ethnic community-based adult population free from 

In the analysis, involving 3579 men and women aged 45 to 84 years, participants reporting work-related stress were less likely to exhibit average or optimal CVH scores based on the American Heart Association (AHA) Life's Simple 7 metrics. Life’s Simple 7 metrics include smoking, physical activity, body mass index (BMI), diet, total cholesterol, blood pressure, and blood glucose.

“To address the public health issue of work-related stress and its detrimental effects on cardiovascular health, future research should prioritize the use of longitudinal studies to identify the mechanisms underlying this association,” said investigators Oluseye Ogunmoroti, MD, MPH, Emory University and Erin Michos, MD, MHS, Johns Hopkins University.

Work-related stress is characterized by detrimental physical and emotional responses from an imbalance between work requirements and a person’s capabilities, resources, or needs. Estimates suggest that 10-40% of workers experience work-related stress and a subsequent elevated risk of adverse CVD outcomes, particularly coronary heart disease (CHD).

Citing the dearth of literature on the correlation between work-related stress and the construct of CVD, Ogunmoroti and colleagues sought to estimate the link between work-related stress and unfavorable CVH in a racially and ethnically diverse sample of adults without known CVD.

Baseline data on 6814 adults free from clinical CVD were obtained between 2000 and 2002 in the Multi-Ethnic Study of Atherosclerosis. The final analytic sample was 3579 after participants with missing observations for variables of interest, retired participants, and unemployed participants were excluded from study.

A self-administered questionnaire evaluated the presence of work-related stress at baseline. Each of Life’s Simple 7 metrics conibuted 0, 1, or 2 points depending on the poor, intermediate, or ideal range, respectively. Aggregated CVH scores were 0 to 14 points, ranging from inadequate (0–8), average (9–10), and optimal (11–14).

A polytomous logistic regression model estimated the independent link between work-related stress and CVH, adjusted for sociodemographic factors, including age, sex, race and ethnicity, and health insurance status. The mean age of participants was 57 years and 48% were women.

Overall, 20% of the study population reported work-related stress—these participants were more commonly younger, women, and White. Compared with participants without work-related stress, those with work-related stress exhibited a lower likelihood of average and optimal CVH scores (odds ratio [OR], 0.75 [95% CI, 0.62–0.92] and OR, 0.73 [95% CI, 0.58–0.92], respectively).

In particular, patients with work-related stress had lower odds of having the ideal physical activity (OR, 0.70 [95% CI, 0.56–0.86]), with similar direction of association between work-related stress and ideal metrics for smoking, BMI, diet, total cholesterol, blood pressure, and blood glucose, although the CIs included the null.

Supplemental analyses revealed no findings of effects by age (<65 versus ≥65 years), sex, or race and ethnicity. Further research found the presence of work-related stress for ≥6 months was linked to a lower likelihood of favorable CVH.

Based on these data, Ogunmoroti and colleagues highlighted the critical nature of workplace wellness programs to manage stress and promote CVH. They called for further research to establish a definitive causal link between work-related stress and unfavorable CVH.

“Conducting thorough workplace intervention studies is essential for the development and implementation of effective stress management strategies that can enhance employee well-being and improve cardiovascular health,” Ogunmoroti and Michos added.

Ogunmoroti O, Osibogun O, Allen NB, et al. Work-Related Stress Is Associated With Unfavorable Cardiovascular Health: The Multi-Ethnic Study of Atherosclerosis. J Am Heart Assoc. Published online November 6, 2024. doi:10.1161/JAHA.124.035824

Work stress increases risk of unfavorable cardiovascular health measures. News. November 6, 2024. Accessed November 6, 2024. https://www.news-medical.net/news/20241106/Work-stress-increases-risk-of-unfavorable-cardiovascular-health-measures.aspx.

Tsao CW, Aday AW, Almarzooq ZI, et al. Heart Disease and Stroke Statistics-2023 Update: A Report From the American Heart Association [published correction appears in Circulation. 2023 Feb 21;147(8):e622. doi: 10.1161/CIR.0000000000001137] [published correction appears in Circulation. 2023 Jul 25;148(4):e4. doi: 10.1161/CIR.0000000000001167]. 

. 2023;147(8):e93-e621. doi:10.1161/CIR.0000000000001123

Articles

A cross-sectional analysis of a multi-ethnic adult population without cardiovascular disease (CVD) found that work-related stress negatively impacts cardiovascular health (CVH). The study, involving 3579 participants aged 45 to 84, used the American Heart Association's Life's Simple 7 metrics to assess CVH. Results indicated that those experiencing work-related stress were less likely to achieve average or optimal CVH scores. The study emphasizes the importance of workplace wellness programs and calls for further research to explore the causal relationship between work-related stress and CVH.

Work-related stress associated with adverse cardiovascular health in diverse US adult population, indicating potential risk factor for CVD prevention.

News

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Clinical

clinical page is a resource for content on every specialty, disease, and topic available on our medical news site.

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

Work-Related Stress Linked to Poor Cardiovascular Health in US Adults

Tim Smith joined the MJH Life Sciences team as an assistant editor for HCPLive in August 2022. He graduated from UC Berkeley with a degree in political science, working in multimedia journalism as a staff writer prior to joining MJH. In his spare time, he enjoys reading, watching TV, listening to podcasts, and rock climbing. You can contact him at 

 during October 2024 features a variety of noteworthy developments in the allergy health space. The team covered a significant number of notable allergy developments, some of which involve new research into 

Other stories covered in October featured new findings on such topics as epinephrine auto-injectors for 

. In all, the month featured an array of different news in the allergy space, allowing patients with allergies as well as clinicians to be more informed regarding the latest advancements.

The following set of stories are a sample of the 

Anaphylm Sublingual Film Achieves Rapid Resolution of Allergen-Related Symptoms

In 1 notable story covered in October, Anaphylm (epinephrine) sublingual film was shown to have achieved the Oral Allergy Syndrome (OAS) challenge study’s key primary and secondary endpoints for the resolving of symptoms of severe allergic reactions such as anaphylaxis. The new findings were announced by Aquestive Therapeutics.

“I am reassured by the speed of symptom relief seen in the OAS study and by the continued and consistent rapid absorption profile of Anaphylm,” Jay Lieberman, MD, a professor of medicine in the department of pediatrics at the University of Tennessee Health Science Center, said in a statement. “These data provide strong evidence that Anaphylm could provide a reliable alternative to the approved epinephrine medical devices currently available to patients.”

Psychology Referrals Rose for Children with Food Allergies in the Past Decade

Another story highlighted data presented at the 2024 American College of Allergy, Asthma, and Immunology (ACAAI) Annual Scientific Meeting, the results of which suggested that psychology referrals dramatically rose for children with food allergies in the prior decade. The study noted the experiences of many patients and children with anxiety surrounding food allergies.

Food allergy-related anxieties were also noted as tending to center around certain phobias and fears, the Allergy & Asthma Network suggests, including fears about allergen safety, needles, allergic reactions, fears of eating out, traveling, anaphylaxis, epinephrine use, rejection, humiliation, bullying, exclusion, and death.

Baked Milk Products Benefit Quality of Life in Milk-Allergic Children

Another October development was the release of data suggesting that adding baked milk products to a child’s regular diet may improve their growth and quality of life among those who are cow’s milk-allergic. These findings had resulted from research conducted over 3 years.

Successful dose escalation to a more allergenic form of milk (MFAM), including pizza, a muffin, rice pudding, or non-baked milk products, was associated with quality of life improvements among children in both 6- and 12-month dose escalation groups.

Infants < 1 Year with Food Allergy Can Safely Eat Low Doses of Causative Food

Additional research covered in October suggested that infants under the age of 1 year old who also had a food allergy may safely consume lower doses of causative foods. Additionally, the investigators of this study indicated that parents should avoid eliminating causative foods in the diets of their infants as they may help them long-term.

“The amount of food that can be consumed without triggering allergic symptoms can be confirmed when a patient passes the [low-dose oral food challenge],” the investigators, led by Mari Takei from the NHO Sagamihara National Hospital in Japan, wrote. “This strategy also reduces the burden on guardians regarding allergic symptoms caused by contamination.”

Study Finds Adrenaline Auto-Injectors Mostly Ineffective Against Fatal Anaphylaxis

Adrenaline auto-injectors were shown in a new study to have little impact on fatal anaphylaxis rates and the injectors’ lack of a sustained plasma adrenaline concentration indicated adrenaline infusion alternatives. These findings, published in Clinical & Experimental Allergy, look at self-administered auto-injectors and the research was authored in part by Marcus Sim, MD, from the National Heart and Lung Institute at Imperial College London.

“Consistent with the findings from in vivo studies in humans, dogs and rats, the steady increase in (adrenaline auto-injectors) availability over the past 35 years has not been accompanied by an equivalent reduction in population rates of fatal anaphylaxis,” Sim and colleagues wrote. “Thus, (adrenaline auto-injectors) may not be reliably effective for preventing fatal anaphylaxis.”

9 Distinct Trajectories Identified in Children with Asthma, Allergy

In another study covered in October, investigators identified 9 trajectories of asthma and allergy among children with distinct differences in longitudinal patterns, parental report and medication use, and classes and frequency of dispensed treatments.

“The present study was strengthened by the use of combined parental report and register data, enriching disease characterization with personal experience and medication utilization,” the research team led by Daniil Lisik, MD, from Krefting Research Centre at Sahlgrenska Academy, University of Gothenburg, wrote.

October 2024 saw significant advancements in allergy research, including new findings on epinephrine auto-injectors and food allergies. Anaphylm sublingual film showed promise in rapidly resolving severe allergic reactions, while psychology referrals for children with food allergies increased over the past decade. Baked milk products were found to improve quality of life in milk-allergic children, and infants with food allergies could safely consume low doses of causative foods. A study questioned the effectiveness of adrenaline auto-injectors against fatal anaphylaxis, and nine distinct asthma and allergy trajectories were identified in children.

In this review of the month of October, some of the most notable advancements and news in the field of allergy were highlighted.

Allergy

Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

Food Allergy

Allergy Month in Review | October 2024

Chelsie Derman is an assistant editor for 

who covers psychiatry, sleep medicine, and geriatrics. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

New phase 3 data showed that patients with schizophrenia on lumateperone (CAPLYTA) 42 mg had a significantly delayed relapse compared to patients on placebo.

 Intra-Cellular Therapies announced the positive results of Study 304, a multicenter, multi-national, randomized, double-blind, placebo-controlled, parallel-group trial, on November 5, 2024.

Lumateperone (10.5 mg, 21 mg, 42 mg), an oral, once-daily atypical antipsychotic, is approved in adults for the treatment of schizophrenia and the treatment of depressive episodes linked to bipolar disorder as a monotherapy or an adjunctive therapy with lithium or valproate.

 Lumateperone is believed to be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.

Research has indicated up to 81.9% of individuals with schizophrenia or schizoaffective disorder experience a relapse within 5 years of their diagnosis, with the global rate between 50 – 92%.

Subsequent relapses also have high rates.

 A schizophrenia relapse leads not only to increases in schizophrenia symptoms but to negative life impacts such as not adhering to medication, job or legal issues, self-harm, and hospitalization.

Study 304 evaluated the efficacy and safety of lumateperone 42 mg for the prevention of symptomatic relapse in adult patients with schizophrenia.

 The 47-week trial started with an 18-week open-label phase where patients with schizophrenia were given lumateperone 42 mg per day. Participants who met the stabilization criteria during the open-label period continued to the double-blind treatment phase.

Participants were randomized to receive lumateperone 42 mg (n = 114) or placebo (n = 114) for up to 26 weeks or until a relapse. The primary endpoint was the time to the first symptom relapse, and the secondary endpoint was the time to all-cause discontinuation during the double-blind phase.

The study revealed the time to relapse during the double-blind treatment phase was significantly longer in patients receiving lumateperone compared with those receiving placebo (

 = .0002). In total, 18 relapses (16.4%) occurred in the lumateperone group versus 44 relapses (38.6%) in the placebo group. Lumateperone was associated with a 63% reduction in risk of relapse compared with placebo (hazard ratio [HR], 0.37; 95% confidence interval [CI], 0.22 – 0.65).

The data shows lumateperone is generally safe and well-tolerated. During the double-blind phase, participants commonly reported headaches, observed among ≥ 5% of the sample and twice the rate of placebo. Other common adverse events observed in previous clinical trials included somnolence/sedation, dizziness, nausea, and dry mouth.

“The control of symptoms and the prevention of relapses is critical to improving long-term patient outcomes,” said Suresh Durgam, MD, executive vice president and chief medical officer of Intra-Cellular Therapies. “We are very pleased that the results from Study 304, a randomized withdrawal trial, demonstrated efficacy along with favorable safety and tolerability which support the benefit of continued long-term treatment with lumateperone.”

Intra-Cellular Therapies Announces Positive Topline Results in Phase 3 Trial Evaluating CAPLYTA for the Prevention of Relapse in Patients with Schizophrenia. Bio Space. November 5, 2024. 

https://www.biospace.com/press-releases/intra-cellular-therapies-announces-positive-topline-results-in-phase-3-trial-evaluating-caplyta-for-the-prevention-of-relapse-in-patients-with-schizophrenia

Campbell, P. Lumateperone Receives FDA Approval For Schizophrenia in Adults. HCPLive. December 23, 2019. 

https://www.hcplive.com/view/lumateperone-fda-approval-schizophrenia-intra-cellular-therapies

Walter, K. FDA Approves Lumateperone for Bipolar Depression. HCPLive. December 20, 2021. 

https://www.hcplive.com/view/fda-approves-lumateperone-bipolar-depression

Rivelli, A., Fitzpatrick, V., Nelson, M. 

 Real-world predictors of relapse in patients with schizophrenia and schizoaffective disorder in a large health system. 

https://doi.org/10.1038/s41537-024-00448-2

Moges S, Belete T, Mekonen T, Menberu M. Lifetime relapse and its associated factors among people with schizophrenia spectrum disorders who are on follow up at Comprehensive Specialized Hospitals in Amhara region, Ethiopia: a cross-sectional study. Int J Ment Health Syst. 2021 May 6;15(1):42. doi: 10.1186/s13033-021-00464-0. PMID: 33957944; PMCID: PMC8101248.

Phase 3 data indicates that lumateperone (CAPLYTA) 42 mg significantly delays relapse in schizophrenia patients compared to placebo. Study 304, a 47-week trial, demonstrated that lumateperone reduced relapse risk by 63% and was generally well-tolerated. The trial involved an 18-week open-label phase followed by a double-blind phase, where patients were randomized to receive lumateperone or placebo. The primary endpoint was time to first symptom relapse, with lumateperone showing a significant advantage. Common adverse events included headaches, somnolence, dizziness, nausea, and dry mouth.

Phase 3 data shows lumateperone 42 mg significantly delayed relapse in patients with schizophrenia vs placebo, with 63% reduced relapse risk and good tolerance.


Psychiatry

Psychiatry condition center page is a comprehensive resource for clinical news and insights on mental illnesses. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for depression, schizophrenia, bipolar disorder, anxiety, and more.

Schizophrenia

The HCPLive schizophrenia page is a resource for medical news and expert insights on the mental disorder. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for schizophrenia, and more.

Phase 3 Data Shows Lumateperone Delays Schizophrenia Relapse Longer Than Placebo

Abigail Brooks is an assistant editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

Patrick Campbell is the managing editor of HCPLive. Formerly the editorial lead of Endocrinology Network, Practical Cardiology, and Rheumatology Network, Patrick has spent years spearheading coverage surrounding cardiometabolic health and rheumatic disease for MJH Life Sciences. He now helps to lead coverage in each of these respective areas for HCPLive. Before joining MJH Life Sciences in 2019, he spent time as a beat reporter with the Pocono Record in Stroudsburg, PA, and Star News Group in Manasquan, NJ. He also touts experience in multimedia, having spent time as a multimedia specialist with NJ Advance Media and multimedia coordinator at the Pocono Record. Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

Victoria Johnson joined the MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and now HCPLive. You can reach her at vjohnson@mjhlifesciences.com

With 2024 quickly drawing to a close, October represented perhaps one of the busiest months of the year in nephrology, owing largely to the plethora of renal news and research produced by the 

American Society of Nephrology’s Kidney Week 2024

, which debuted its first 3 episodes with a trio of guests from ASN Kidney Week. A hot topic at the meeting and the focus of one of these 

 was a major area of nephrology research this month.

 October 2024 nephrology month in review for highlights of our coverage of the biggest renal headlines from the past few weeks!

VALIANT: Pegcetacoplan Offers Benefit for UPCR, eGFR, C3 Staining in C3G, IC-MPGN

Data from the VALIANT trial presented at 

 provide evidence positioning pegcetacoplan (Empaveli), a complement inhibitor targeting C3/C3b, as the first therapy to offer clinically meaningful benefits for proteinuria, C3c staining, and eGFR stabilization in patients with C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN).

The full presentation of VALIANT comes less than 3 months after Sobi and Apellis Pharmaceuticals announced topline results and sheds additional light on the safety and efficacy of pegcetacoplan for a pair of rare kidney diseases without approved treatments. Based on these data, Sobi and Apellis intend to file a supplemental New Drug Application to the US Food and Drug Administration in early 2025.

Carla Nester, MD: Pegcetacoplan in C3 Glomerulopathy and Primary IC-MPGN

Carla Nester, MD, discusses her perspective on VALIANT data and the role of pegcetacoplan in C3G and IC-MPGN

HCPLive Nester VALIANT ASN 2024

DUPLEX: Sparsentan Could Offer Greater Benefit in Genetic FSGS

A posthoc analysis of DUPLEX, the largest clinical trial to date in 

focal segmental glomerulosclerosis (FSGS)

, suggests patients with genetic FSGS (gFSGS) could benefit from sparsentan (Filspari) similar to patients with other forms of FSGS. The analysis was presented almost exactly 1 year after the presentation of the original DUPLEX trial, with results indicating patients with gFSGS experienced a more pronounced antiproteinuric response with sparsentan that was sustained across the duration of the study period.

Semaglutide Shows Promise, Reduces UACR in Nondiabetic Kidney Disease

Semaglutide (Ozempic) may be useful as a treatment for the management of 

 without diabetes, according to findings from recent research. The 6-month trial compared use of semaglutide 2.4 mg against placebo therapy in patients with obesity and nondiabetic CKD, with results suggesting use of the GLP-1 receptor agonist was associated with a placebo-corrected 52.1% reduction in urine albumin-to-creatinine ratio (UACR).

New Podcast Alert: Kidney Compass Debuts on 

Kidney Compass: Navigating Clinical Trials

, a guide to the latest in clinical trials and relevant updates in the world of nephrology—created by Brendon Neuen, MBBS, PhD, and Shikha Wadhwani, MD, MS, to make the changing landscape of nephrology and clinical trials within the specialty easier to understand and navigate.

The podcast features insights from Neuen and Wadhwani, but also special guests, including some of the leading trialists in the space. At ASN Kidney Week, the duo spoke with 3 experts about new trial data being presented at the meeting for the podcast’s first 3 episodes:

Kidney Compass: Atacicept for IgAN with Jonathan Barratt, MD, PhD, at Kidney Week 2024

Kidney Compass: Semaglutide for Nondiabetic Kidney Disease, with Hiddo Heerspink, PhD, PharmD, at Kidney Week 2024

Kidney Compass: FLOW Insights from Kidney Week 2024, with Katherine Tuttle, MD

Gender, IgA Nephropathy Linked to Gross Hematuria After COVID-19 Vaccination

’s most popular nephrology coverage from October was a summary of findings from a prospective nationwide multicenter cohort study conducted across 22 hospitals in Japan suggesting female patients and patients with IgAN and IgA vasculitis (IgAV) are more likely to experience gross hematuria following receipt of the COVID-19 mRNA vaccine. Beyond the apparent sex and IgAN/IgAV bias, results also suggest specific galactose-deficient IgA1 (Gd-IgA1) and the adaptive immune system may be involved in the development of gross hematuria following vaccination.

ORIGIN OLE Data Solidify Atacicept Disease-Modifying Potential for IgA Nephropathy

New 96-week data from the open-label extension portion of the ORIGIN trial suggest use of atacicept could slow the rate of kidney decline in patients with IgAN to a rate similar to physiological aging without kidney disease. Results of the trial show use of atacicept, a dual BAFF/APRIL inhibitor from Vera Therapeutics, was associated with sustained reductions in Gd-IgA1, hematuria, and UPCR, positioning atacicept as a disease-modifying therapy and representing an important potential advancement in the future management of IgAN.

Felzartamab Slows IgAN Decline in New Phase 2 Data

Felzartamab is well-tolerated, leads to sustained proteinuria reductions, and reduces eGFR decline in patients with IgAN compared to placebo, according to new 24-month data from the randomized, double-blind, placebo-controlled phase 2a IGNAZ study. A monoclonal antibody, felzartamab targets CD38 on plasma cells, which is suspected to be the source of pathogenic Gd-IgA1 and autoantibodies in IgAN.

October 2024 was a significant month for nephrology, highlighted by the American Society of Nephrology’s Kidney Week. Key developments included the VALIANT trial, which demonstrated pegcetacoplan's benefits for C3 glomerulopathy and IC-MPGN, and the DUPLEX trial's findings on sparsentan for genetic FSGS. Semaglutide showed promise in reducing UACR in nondiabetic CKD. The debut of the Kidney Compass podcast provided insights into clinical trials. New research on IgA nephropathy explored gender-linked hematuria post-COVID-19 vaccination and the potential of atacicept and felzartamab as disease-modifying therapies.

This nephrology month in review spotlights HCPLive’s coverage of ASN Kidney Week, the debut of a new podcast, and new research on IgA nephropathy.

Nephrology

The HCPLive nephrology page is a resource for medical news and expert insights on kidney disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in nephrology, and more.

IgA Nephropathy

The HCPLive Berger disease page is a resource for medical news and expert insights on IgA nephropathy. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in Berger disease, and more.

Nephrology Month in Review: October 2024

The FDA has accepted Organon and Shanghai Henlius Biotech’s biologics license application for HLX14, a 

Denosumab is FDA-approved to treat postmenopausal women at high risk for fracture, patients with intolerance or inadequate response to other osteoporosis treatments, and patients who will be taking corticosteroids for ≥6 months and are at a high risk for fracture. The drug is also used to increase bone mass in men with osteoporosis at a high risk for fracture and men at a high risk for fracture treated with certain medications for prostate cancer.

The BLA is based on data from comparative quality analytical studies and 2 clinical studies, among other head-to-head studies for HLX14. One such study was a 2-part phase 1 clinical study in Chinese healthy adult male participants with the first part being an open-label, randomized, parallel-controlled, single-dose, pilot study comparing the pharmacokinetic parameters of HLX14 and PROLIA after subcutaneous and the second part a double-blind, randomized, parallel-controlled, single-dose, 4-arm study comparing the pharmacokinetic similarity of HLX14 with PROLIA after subcutaneous injection. Another study was a randomized, double-blind, international multicenter, parallel-controlled phase 3 clinical study comparing the efficacy, safety, tolerability, and immunogenicity of HLX14 with reference PROLIA in postmenopausal women with osteoporosis at high risk for fracture.

Organon was granted exclusive commercialization rights to HLX14 and another biosimilar candidate in a 2022 a license and supply agreement with Henlius in markets markets such as the United States, the European Union, and Canada, but not China.

The FDA approved the first denosumab biosimilars, 2 formulations of denosumab-bddz marketed under the names Wyost and Jubbonti, in March 2024.

 Wyost is a denosumab-bddz 120 mg/1.7 mL (70 mg/mL) injection approved to reduce the risk of skeletal-related events (SREs) in patients with multiple myeloma and for those with bone metastases from solid tumors, to treat adult patients with skeletally mature adolescents with giant cell tumor of bone which is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.

Jubbonti is a 60 mg/1 mL injection of the denosumab-bbdz is approved to treat postmenopausal women with osteoporosis who are at a high risk for fracture, to increase bone mass in men with osteoporosis who are at a high risk for fracture, and to increase bone mass in men at high risk for fracture who are being treated with androgen deprivation therapy for nonmetastatic prostate cancer. It is also approved to treat glucocorticoid-induced osteoporosis and to increase bone mass in women at high risk for fracture who are being treated with adjuvant aromatase inhibitor therapy for breast cancer.

“Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events, which are disease states that can profoundly reduce quality of life for patients,” said Keren Haruvi, President Sandoz North America, in a statement.

 “I am proud that Sandoz continues to pioneer access to these life-changing medicines for the patients who need them most."

US FDA Accepts Biologics License Application (BLA) for HLX14, Biosimilar Candidate of PROLIA/XGEVA (denosumab). News release. Organon. October 30, 2024. https://www.businesswire.com/news/home/20241029648679/en/US-FDA-Accepts-Biologics-License-Application-BLA-for-HLX14-Biosimilar-Candidate-of-PROLIAXGEVA-denosumab

Prolia (denosumab): Other approved indications. Prolia.com. (n.d.). https://www.prolia.com/proven-prolia-results/other-approved-indications

Sandoz International GmbH. Sandoz receives FDA approval for first and only denosumab biosimilars. GlobeNewswire News Room. March 5, 2024. Accessed March 5, 2024. https://www.globenewswire.com/news-release/2024/03/05/2840809/0/en/Sandoz-receives-FDA-approval-for-first-and-only-denosumab-biosimilars.html.

The FDA has accepted the biologics license application for HLX14, a denosumab biosimilar developed by Organon and Shanghai Henlius Biotech. Denosumab is used to treat osteoporosis and increase bone mass in patients at high risk for fractures. The application is supported by comparative quality analytical studies and clinical trials, including a phase 3 study in postmenopausal women. Organon holds exclusive commercialization rights in several markets. The FDA previously approved the first denosumab biosimilars, Wyost and Jubbonti, for various indications related to bone health and cancer-related skeletal events.

If approved, HLX14 would follow the first 2 denosumab biosimilar approvals in March 2024.

Biosimilars

FDA News

FDA Accepts BLA for Denosumab Biosimilar

Videos

This interview with Kraft features a discussion regarding her team’s new data from the BATURA study on albuterol for patients’ asthma exacerbations.

Asthma

The HCPLive asthma page is a comprehensive resource for clinical news and insights on asthmatic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for allergic and severe asthma, and more.

Monica Kraft, MD: Discussing Phase 3b Findings on Albuterol/Budesonide for Asthma

Teva presents 2 findings at Psych Congress 2024: TEV’749’s effects on social function and quality of life in adults with schizophrenia and risperidone adherence patterns.

Phase 3 Data Shows TEV-‘749 Injection Improves Social Function in Schizophrenia

Noureddin explains the efficacy of resmetirom doses and how they vary based on patients’ body weight and BMI, supporting current prescribing practices.

Hepatology

MASH / MASLD

The HCPLive MASH & MASLD page is a comprehensive resource for clinical news and insights on metabolic dysfunction-associated steatotic liver disease and steatohepatitis. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for fatty liver disease, steatohepatitis, and more.

Mazen Noureddin, MD: Differences in Resmetirom Efficacy Based on Body Weight, BMI

MASEF score seemed to be sensitive and effective in detecting at-risk MASH in 2 abstracts presented at the ACG 2024 Meeting. 

Conference

 conference coverage page features articles, videos, and expert-led live coverage from major medical meetings throughout the year.

MASEF Score May Top FIB-4, Clinical Screening for Early MASH Detection 

Survey data show pharmacists are integral to HCV screening and treatment across healthcare settings, highlighting their contributions to HCV elimination efforts.








Hepatitis C

Hepatitis C page, resources on the topics of medical news and expert insight into HCV can be found. Content includes articles, interviews, videos, podcasts, and breaking news on hepatitis C virus research, treatment, and drug development.

Survey Highlights Critical Role of Pharmacists in HCV Management

Investigators highlighted the long-term cost-effectiveness of routine HCV screening as well as linkage-to-care for high-risk patients in emergency departments.

Emergency Department HCV Screening May Reduce Potential Hepatic Complications, Lower Costs

Chronic hepatitis B patients with HBsAg <100 IU/mL and HBcrAg <3 log U/mL at nucleot(s)ide analog therapy had lower relapse risk.

Low HBsAg Levels During Nucleotide Analog Therapy Brings Favorable Prognostic Outcomes

Phase 3, 3b, and 4 clinical trials will provide long-term insight into the use of elafibranor in different PBC patient populations and real-world settings.

Cholangitis

cholangitis page, resources on the topics of medical news and expert insight into cholangitis can be found. Content includes articles, interviews, videos, podcasts, and breaking news on research, treatment, and drug development in PBC, PSC, and more!

Understanding Elafibranor (Iqirvo) for PBC: Insight From New Clinical Trials

Direct-acting antiviral agents have enabled more availability for organ transplant.  

HCV+ Organs Offer Better Waitlist, Survival Outcomes for Transplantation 

This hepatology month in review spotlights hepatic pipeline news, research on treating and eliminating viral hepatitis, and HCPLive’s coverage of ACG 2024.

Latest News

Work-Related Stress Linked to Poor Cardiovascular Health in US Adults

Allergy Month in Review | October 2024

Phase 3 Data Shows Lumateperone Delays Schizophrenia Relapse Longer Than Placebo

Nephrology Month in Review: October 2024

FDA Accepts BLA for Denosumab Biosimilar