FDA grants priority review to sotatercept for pulmonary arterial hypertension
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The FDA has granted priority review to sotatercept, a novel activin signaling inhibitor designed to treat adults with pulmonary arterial hypertension, according to a manufacturer-issued press release.
The FDA based this decision, in part, on data from the phase 3, randomized, double-blind, placebo-controlled STELLAR trial, which showed that sotatercept (Merck) plus background therapy lowered the risk for death and clinical worsening by 84% in PAH.
As Healio previously reported, data presented at the American College of Cardiology Scientific Session showed the sotatercept group also demonstrated improvement in 6-minute walk distance by 40.1 m (95% CI, 29.9-50.2) between baseline and week 24 of treatment compared with a decline of –1.4 m (95% CI, –13.2 to 10.3; P < .001) in the placebo group.
Notably, patients receiving sotatercept also outperformed patients receiving placebo in eight out of nine assessed secondary endpoints, according to the release and results published in The New England Journal of Medicine.
Healio also recently reported that sotatercept plus background therapy is projected to increase life expectancy in PAH by three-fold vs. background therapy alone.
The Prescription Drug User Fee Act goal deadline is March 26, 2024, according to the release.
“Despite advances in the treatment of PAH over the last 2 decades, there is still a significant need to improve outcomes for patients,” Joerg Koglin, MD, PhD, senior vice president of global clinical development at Merck Research Laboratories, said in the release. “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.”