FDA Grants Priority Review to Sotatercept for Pulmonary Arterial Hypertension
29 Sept 2023 • The US Food and Drug Administration (FDA) has accepted priority review for sotatercept, a novel investigational activin signaling inhibitor, for the treatment of adults with pulmonary arterial hypertension (PAH).
Presented at the 2023 American College of Cardiology (ACC) Annual Scientific Sessions, the results showed sotatercept on top of background therapy led to a statistically significant and clinically meaningful improvement in 6-minute walk distance. In addition, sotatercept met 8 of 9 secondary endpoints, including the proportion of participants achieving multi-component improvement.
If appproved, Sotatercept - a potential first-in-class activin signaling inhibitor biologic would be the first drug in its class for treating PAH. The FDA is expected to base its decision in part on data from the STELLAR clinical trial, which compared 163 adult PAH patients treated with subcutaneous sotatercept every three weeks, with another 160 patients treated with a placebo. The full results of the STELLAR trial were published in the New England Journal of Medicine back in March.
In addition to STELLAR, the sotatercept clinical development program includes multiple Phase 2 and 3 trials across a broad range of patients. Studies are underway in adult patients with PAH (WHO Group 1) at intermediate or high risk of disease progression or mortality, as well as with pulmonary hypertension due to left heart disease (WHO Group 2)
Sotatercept has previously received the FDA’s Breakthrough Therapy designation and Orphan Drug designation.
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