Merck Gets Priority Review For Biologics License Application For Sotatercept

(RTTNews) - 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).