The US Food and Drug Administration (FDA) has given the green light to Merck’s (known as MSD outside the US) biologics license application (BLA) for sotatercept, marking it for priority review as a potential treatment for pulmonary arterial hypertension (PAH) classified under WHO Group 1. Sotatercept, an investigational activin signaling inhibitor, is intended for use in adult PAH patients.Pulmonary Arterial Hypertension
A regulatory decision regarding the therapy’s approval is expected to be announced on March 26, 2024.
Merck submitted the BLA for sotatercept based on compelling results from the Phase III STELLAR clinical trial. During the trial, sotatercept, when combined with background therapy, demonstrated significant improvements in the six-minute walk distance (6MWD) and eight out of nine secondary outcomes.
If granted FDA approval, sotatercept will represent a groundbreaking approach to managing this rare condition affecting the pulmonary arteries.
Dr. Joerg Koglin, Senior Vice President of Global Clinical Development at Merck Research Laboratories, emphasized the pressing need to enhance outcomes for PAH patients, despite advancements in treatment options over the past two decades. He expressed excitement over the FDA’s acceptance of the application, highlighting it as a significant milestone in their mission to make this innovative activin signaling inhibitor accessible to patients.
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