Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The US Food and Drug Administration (FDA) has granted priority review for MSD’s supplemental biologics license application (sBLA) for Winrevair (sotatercept-csrk).
WINREVAIR was initially approved in 2024 to treat adult people with pulmonary arterial hypertension. Credit: Robina Weermeijer on Unsplash.
Subscribe to our email newsletter
This sBLA seeks to update the US product label reflecting the results from the Phase III ZENITH trial.
Winrevair was initially approved in 2024 to treat adult people with pulmonary arterial hypertension (PAH, Group 1 PH) for improving exercise capacity, WHO functional class (FC), and minimise clinical worsening events risk.
The FDA has set a target action date of 25 October 2025, under the Prescription Drug User Fee Act (PDUFA).
The global, double-blind, placebo-controlled clinical study enrolled 172 participants who were randomised equally to receive either Winrevair plus background PAH therapy or a placebo plus background PAH therapy.
Merck Research Laboratories global clinical development senior vice-president Dr Joerg Koglin said: “We are pleased that the FDA has accepted our sBLA for Winrevair and granted a priority review to consider an update to labelling for Winrevair to include the impressive results of ZENITH.
“There remains a significant unmet medical need for patients living with PAH who, despite being on background therapy, remain at higher risk of morbidity and mortality.”
In the ZENITH trial, Winrevair demonstrated a 76% decline in the risk of a composite of all-cause death, lung transplantation, and hospitalisation for PAH lasting 24 hours or more against placebo.
Improvements were observed early on, with increasing benefits throughout the study. Winrevair’s safety profile in the trial was found to be generally consistent with that observed in earlier studies.
Currently, the therapy is approved in over 45 nations, with its initial approval based on the results from the STELLAR trial.
