FDA accepts priority review for sotatercept to treat PAH in adults

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The U.S. Food and Drug Administration (FDA) has accepted for priority review Merck’s new Biologics License Application (BLA) for sotatercept, an activin signaling inhibitor, for the treatment of pulmonary arterial hypertension (PAH) in adults. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of March 26, 2024. 

Merck’s application is based on clinically meaningful results from its phase 3 STELLAR trial. The data, published in April 2023 in The New England Journal of Medicine, demonstrated that sotatercept in addition to background therapy improved PAH patients’ 6-minute walk distance and eight of nine secondary outcome measures. If approved by the FDA, the investigational drug would be the first in its class.

“Despite advances in the treatment of PAH over the last two decades, there is still a significant need to improve outcomes for patients,” said Joerg Koglin, MD, senior vice president, global clinical development, Merck Research Laboratories. “The FDA’s acceptance of this application is an exciting milestone in our journey to bring this novel activin signaling inhibitor to patients. Based on the profound improvements across primary and secondary outcome measures in the phase 3 STELLAR trial, we believe sotatercept has the potential to transform the treatment of patients with PAH. We look forward to working closely with the FDA to bring sotatercept to patients in need.”

In addition to the STELLAR trial, Merck’s sotatercept clinical development program includes several phase 2 and 3 trials across a broad range of patients. Further studies are currently ongoing in adult patients who have PAH (WHO Group 1) and are at intermediate or high risk of disease progression or mortality, as well as in patients who have PAH due to left heart disease (WHO Group 2). 

The FDA already has granted sotatercept with Breakthrough Therapy designation and Orphan Drug designation, and the European Medicines Agency (EMA) has given it Priority Medicines designation and Orphan Drug designation for the treatment of PAH.

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