Managed Healthcare Executive March 30, 2024
This week, the FDA approved two therapies for pulmonary arterial hypertension: Merck’s first in class therapy Winrevair and J&J’s oral combination tablet Opsynvi. The agency also approved Vafseo, a new treatment for anemia in kidney disease. The FDA granted full approval to the cancer drug Elahere and extended the indication of Vemlidy to children. Regulators also issued a CRL for odronextamab for lymphoma indications
FDA Approves Merck’s Drug for Pulmonary Arterial Hypertension
The FDA has approved Winrevair (sotatercept-csr), Merck’s therapy to treat adults with pulmonary arterial hypertension (PAH). PAH is caused by the growth of cells in the arterial walls in the lung, leading to narrowing and abnormal constriction. Winrevair is a first-in-class activin signaling inhibitor. It is given once...