The HCPFive: Top News for Healthcare Providers from the Week of 05/11

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 tirzepatide outperforming semaglutide in weight loss outcomes, a steroid-sparing benefit of crinecerfont, increased cardiovascular risk tied to adult-onset type 1 diabetes (T1D), US Food and Drug Administration (FDA) review of berotralstat granules for young hereditary angioedema (HAE) patients, and progress toward approval of sparsentan for focal segmental glomerulosclerosis.

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 May 11, 2025—let’s jump in!

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

FDA Accepts Sparsentan (Filspari) sNDA for Focal Segmental Glomerulosclerosis

The FDA accepted Travere Therapeutics’ supplemental New Drug Application (sNDA) for traditional approval of sparsentan (Filspari) for the treatment of focal segmental glomerulosclerosis (FSGS). The regulatory agency assigned a PDUFA target action date of January 13, 2026, and will hold an advisory committee meeting to discuss the application.

FDA Accepts BioCryst’s NDA for Berotralstat Oral Granules in Children With HAE

The FDA accepted the New Drug Application for berotralstat (ORLADEYO) oral granules in patients with hereditary angioedema (HAE) aged 2 to 11 years. The application received a PDUFA target action date of September 12, 2025, and its approval would mark the first oral prophylactic therapy targeted for patients with HAE under 12 years.

SURMOUNT-5: Tirzepatide (Zepbound) Proves Benefit over Semaglutide (Wegovy) for Obesity

Full data from the SURMOUNT-5 trial reveals key differences between the effects of tirzepatide (Zepbound) and semaglutide 2.4 mg (Wegovy) for the treatment of obesity. In the trial, tirzepatide achieved a greater magnitude of benefit for percent change in body weight, absolute weight loss, and proportion of patients achieving predefined weight loss thresholds.

Related Content: Diabetes Dialogue: Tirzepatide vs Semaglutide for Obesity, Understanding SURMOUNT-5

Crinecerfont Reduces Steroid Use for Pediatric CAH in Phase 3 Analysis

Crinecerfont (CRENESSITY) reduced glucocorticoid dosing while maintaining or improving androstenedione levels in pediatric patients with classic congenital adrenal hyperplasia (CAH) in the Phase 3 CAHtalyst Pediatric study. Similar benefits were identified across all patient subgroups, irrespective of demographics or baseline hormone levels.

Type 1 Diabetes Diagnosed in Adulthood Heightens Cardiovascular Risk

T1D development in adulthood elevated the risk of cardiovascular disease (CVD) and death, with diagnosis at age ≥40 years not related to an improved prognosis compared with an earlier diagnosis. Using nationwide data in Sweden over 20 years, those with T1D experienced a higher incidence of all-cause mortality, major adverse cardiovascular events, and mortality from CVD or non-CVD-related diseases, compared with controls.