Cardiology Month in Review: January 2025

Hitting the ground running in 2025, the field of cardiology experienced a bustling start to the year, with a trio of notable decisions from the US Food and Drug Administration (FDA), two pipeline updates on key therapies, and a plethora of study data on key trends across the nation on cardiac treatment.

In our January 2025 month in review, we provide a recap of the news and stories that defined this past month in cardiology, focusing on regulatory updates, developments to the pipeline, and new data from multiple subspecialties in cardiology, including cardiopulmonary health, heart failure (HF), and lipidology.

Here’s what happened in January:

FDA Accepts Plozasiran NDA for Familial Chylomicronemia Syndrome

The FDA accepted the NDA for investigational plozasiran for the treatment of familial chylomicronemia syndrome (FCS), assigning a Prescription Drug User Fee Act (PDUFA) target date of November 18, 2025. The NDA was accepted based on a review of positive data from the Phase 3 PALISADE study, with no calls for an advisory committee meeting from the agency.

FDA Accepts New Drug Application for Bumetanide Nasal Spray

The FDA also accepted the NDA for Bumetanide Nasal Spray, assigning a Prescription Drug User Fee Act (PDUFA) target action date of September 14, 2025. Bumetanide nasal spray is an investigational drug in development as an outpatient-focused therapy for edema associated with congestive heart failure, as well as liver and kidney disease.

FDA Grants 510(k) Clearance to First Lp(a) Blood Test in Molar Units

The FDA granted 510(k) clearance to Roche’s Tina-quant® Lipoprotein (a) Gen.2 Molarity assay, marking the first blood test cleared for the US market to measure lipoprotein (a) [Lp(a)] in molar units. The Tina-quant Lipoprotein (a) Gen.2 Molarity assay could aid the evaluation of lipid metabolism disorders and atherosclerotic cardiovascular disease (ASCVD) risk when used in conjunction with clinical assessment and other lipoprotein tests.

Bayer Submits Finerenone Application to FDA for Treatment of Heart Failure

Bayer submitted a supplemental New Drug Application (NDA) to the FDA for finerenone (KERENDIA) for the treatment of HF with left ventricular ejection fraction (LVEF) ≥40%. The submission was based on positive data from the Phase 3 FINEARTS-HF study showing finerenone statistically significantly reduced the composite endpoint of cardiovascular death and total HF events by 16%.

Merck Halts Phase 3 HYPERION Trial of Sotatercept for Final Analysis

Merck stopped the Phase 3 HYPERION trial evaluating sotatercept-csrk (WINREVAIR) versus placebo in adults with recently diagnosed pulmonary arterial hypertension (PAH) early, announcing plans to proceed with the final analysis. The company attributed the trial's halt to the robust efficacy benefit of sotatercept in the PAH clinical development program, including the STELLAR and ZENITH studies, which led to a loss of clinical equipoise in HYPERION.

Cardiac Uptake Reflects Risk in Asymptomatic ATTR Cardiac Amyloid Infiltration

Clinical phenotypes affected the prognosis of patients with asymptomatic transthyretin (ATTR) cardiac amyloid infiltration, including rates of disease progression and the risk of cardiovascular (CV) death, in new research. Among nearly 500 patients, grade 2 or 3 cardiac uptake was linked to greater disease progression rates and a 5-fold higher risk of CV death, while grade 1 cardiac uptake revealed a predominance of non-CV death.

National Trends in Preventive Aspirin Use Shaped by ASCVD Risk

Self-reported primary prevention aspirin use decreased among older adults and adults with low ASCVD risk but additionally lowered among adults with higher ASCVD risk. Recommendations from the American College of Cardiology/American Heart Association (ACC/AHA) narrowed the patient population for preventive aspirin use to those at higher ASCVD risk and ≤70 years old without increased bleeding risk.

Medicaid Status May Worsen Complications After Heart Transplantation

Heart transplant recipients with Medicaid reported an elevated risk of cardiac allograft vasculopathy (CAV) development over 5 years. Among more than 37,000 adults, those with Medicaid insurance experienced worse survival rates in those 5 years, particularly those on Medicaid in the post-Affordable Care Act (ACA) era (2014-2022).

Cardiac Biomarker Testing Underutilized in US Emergency Departments

Cardiac biomarker testing in US emergency departments (EDs) used to determine the risk of acute coronary syndrome (ACS) revealed that 7% of all presenting patients underwent testing, with approximately two-thirds reporting no chest pain. Rates of ACS were ≥2% among the subgroup without chest pain, remaining below a benefit-risk threshold for myocardial infarction screening.

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