The U.S. Food and Drug Administration (FDA) has agreed to review an application seeking approval of sotatercept as a treatment for adults with pulmonary arterial hypertension (PAH).
The FDA has given the application priority review, shortening the review time from the usual 10 months to six months. A decision is expected by March 26.
“The FDA’s acceptance of this application is an exciting milestone in our journey to bring this novel activin signaling inhibitor to patients,” Joerg Koglin, MD, PhD, senior vice president of global clinical development at Merck Research Laboratories, said in a company press release. Merck acquired exclusive rights to sotatercept in pulmonary hypertension through the acquisition of Acceleron Pharma.