The HCPFive: Top News for Healthcare Providers from the Week of 04/13

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.

Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include US Food and Drug Administration (FDA) approvals for maralixibat tablets and dupilumab—marking key advances in rare disease and allergy care. Positive trial data for orforglipron, combination lipid-lowering therapy, and aflibercept 8 mg also signal important shifts in how we treat diabetes, cardiovascular disease, and retinal conditions.

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of April 13, 2025—let’s jump in!

Interested in oncology news? Check out The OncFive, from our sister publication OncLive.

FDA Approves Maralixibat (Livmarli) Tablet for Alagille Syndrome, PFIC

On April 14, 2025, the FDA approved a new tablet formulation of Mirum Pharmaceuticals’ maralixibat (Livmarli) for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC). Maralixibat tablets are planned to be available in June through Mirum Access Plus, and the drug is being evaluated further in the phase 3 EXPAND study in additional settings of cholestatic pruritus.

Combination of Statins, Ezetimibe Could Prevent Thousands of Heart Attacks

Combination lipid-lowering therapy (LLT) with statins and ezetimibe could prevent thousands of further cardiovascular events among patients hospitalized with myocardial infarction (MI), according to new research from Lund University and Imperial College London. The adjusted hazard ratio of major adverse cardiovascular events (MACE) over 3 years was 1.14 for those receiving ezetimibe and 1.29 for those not receiving combination therapy.

FDA Accepts Aflibercept 8 mg for Priority Review to Treat Retinal Vein Occlusion

On April 17, 2025, the FDA accepted for Priority Review the supplemental Biologics License Application (sBLA) for aflibercept 8 mg (EYLEA HD) for the treatment of macular edema following retinal vein occlusion (RVO) and for monthly dosing in approved indications. An approval would establish aflibercept 8 mg as the first RVO treatment eligible for every 8-week dosing after an initial monthly period.

Oral GLP-1 Orforglipron Hits Target in Phase 3 Diabetes Trial

Topline results from ACHIEVE-1 reported oral orforglipron as effective and safe for adults with type 2 diabetes (T2D) inadequately controlled by diet and exercise. Eli Lilly and Company’s once-daily glucagon-like peptide-1 (GLP-1) receptor agonist achieved statistically significant reductions in hemoglobin A1c and body weight in the Phase 3 trial, and its safety profile remained consistent with the injectable therapies from the drug class.

FDA Approves Dupilumab (Dupixent) for Chronic Spontaneous Urticaria

On April 18, 2025, the FDA approved dupilumab (Dupixent) for the treatment of patients aged 12 years and older with chronic spontaneous urticaria (CSU) for whom CSU is uncontrolled with H1-antihistamines. The approval, marking the first new targeted therapy in more than a decade for CSU, was based the Phase 3 LIBERTY-CSU CUPID Study A and Study C trials.