The US Food and Drug Administration has approved sotatercept, Merck‘s new drug for pulmonary arterial hypertension. It’s commercial name is Winrevair. Read more on the FDA website at this link
Sotatercept is an activin receptor type IIA-Fc (ActRIIA-Fc) fusion protein. It was evaluated as an add-on to stable background therapy for the treatment of pulmonary arterial hypertension in Merck’s the pivotal STELLAR study. The drug is a subcutanous injection administered every three weeks and is distributed in single-vial or double-vial kits.
Merck had announced on September 28, 2023 that that the FDA has accepted to give priority review for sotatercept and had set the target action date of March 26, 2024. Merck also submitted an application to the European Medicine’s Agency on
Read more about the Stellar study at this link
Photo credit: Photo by Diana Polekhina on Unsplash
