FDA Grants Priority Review To Merck’s SBLA For Winrevair After Early Success In ZENITH PAH Trial - Data Intelligence

FDA grants priority review for MSD’s WINREVAIR sBLA

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 The post FDA grants priority review for MSD’s Winrevair appeared first on Pharmaceutical Business review.

FDA Grants Priority Review To Merck’s SBLA For Winrevair After Early Success In ZENITH PAH Trial - Data Intelligence

Credit: samunella | stock.adobe.com Key takeaways Early trial termination for efficacy signals strong clinical benefit: The ZENITH trial was halted ahead of schedule due to overwhelming efficacy, underscoring the importance of robust interim analyses and data monitoring planning. Priority review highlights regulatory momentum: The FDA’s acceptance and expedited review of Merck’s sBLA for Winrevair reflects how strong clinical outcomes can accel…

FDA Accepts Application for Sotatercept-csrk Label Expansion in PAH

The results of the ZENITH trial have encouraged the expansion of sotatercept’s label to patients with prior background therapy.