KENILWORTH (NJ) (dpa-AFX) - Merck & Co., Inc. (MRK) (MRK) on Thursday said its Biologics License Application (BLA) for Sotatercept to treat pulmonary arterial hypertension has been accepted for priority review by the Food and Drug Administration (FDA).
A decision from the regulator is expected on March 26, 2024.
PAH is a progressive disorder characterized by the narrowing of blood vessels in the lungs that causes significant strain on the heart.
The BLA is based on data from the Phase 3 STELLAR trial, in which Sotatercept on top of background therapy showed a statistically significant improvement in 6-minute walk distance (6MWD).
Copyright(c) 2023 RTTNews.com. All Rights Reserved
Copyright RTT News/dpa-AFX
© 2023 AFX News
