FDA Approves Winrevair for Pulmonary Arterial Hypertension in Adults
By Lori Solomon HealthDay Reporter
THURSDAY, March 28, 2024 -- The U.S. Food and Drug Administration has approved Winrevair (sotatercept-csrk) as an injectable treatment for pulmonary arterial hypertension (PAH) in adults.
The FDA previously granted Winrevair a breakthrough therapy designation. It is the first FDA-approved activin signaling inhibitor therapy for PAH, representing a new class of therapy. Winrevair works by improving the balance between pro- and antiproliferative signaling to regulate the vascular cell proliferation underlying PAH.
The approval was based upon data from the phase 3 STELLAR trial, which compared Winrevair (163 patients) to placebo (160 patients) in adult patients with PAH. Findings show that adding Winrevair to background standard-of-care therapy increased six-minute walk distance from baseline to week 24 by 41 meters. Significant improvements were also seen in the secondary outcome measures of risk of death from any cause and PAH clinical worsening events by 84 percent (number of events, nine versus 42; hazard ratio, 0.16).
"New treatment options continue to be needed for patients with pulmonary arterial hypertension that support important clinical goals, including increasing exercise capacity and improving functional class," STELLAR study investigator Aaron Waxman, M.D., of Brigham and Women's Hospital in Boston, said in a statement. "Sotatercept added to background therapy has the potential to become a new standard-of-care option for patients with pulmonary arterial hypertension."
Approval of Winrevair was granted to Merck.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2024 HealthDay. All rights reserved.
Posted March 2024
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.