BioPharma Dive March 26, 2024
Cleared for pulmonary arterial hypertension, Winrevair is expected to become a blockbuster product for Merck. But its potential could hinge on the results of a few ongoing trials.
The Food and Drug Administration on Tuesday approved a new Merck & Co. drug to treat pulmonary arterial hypertension. Called Winrevair, the drug is the first treatment that targets the underlying cause of the lung condition, which typically leads to death within a decade of diagnosis.
The FDA’s approval was based on clinical trial data showing Winrevair improved exercise duration and quality of life, as well as delayed death or worsening of the disease.
The shot, known scientifically as sotatercept, blocks proteins that contribute to the thickening of blood vessel walls in...