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September 29, 2023

Merck gains FDA priority review for sotatercept BLA

The US Food and Drug Administration (FDA) has accepted Merck’s (MSD) biologics license application (BLA) of sotatercept to treat pulmonary arterial hypertension [PAH (WHO Group 1)], for priority review.

Merck filed BLA for sotatercept based on findings from the Phase III STELLAR clinical trial in pulmonary arterial hypertension patients. Credit: Yale Rosen from USA /