Merck & Co. Inc. (MRK) announced that the U.S. Food and Drug Administration (FDA) has approved an update to the product label for WINREVAIR for Injection, 45mg and 60mg. The approval is based on data from the Phase 3 HYPERION trial.
The HYPERION trial was a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of WINREVAIR in patients with pulmonary arterial hypertension (PAH). The study results were presented at the 2024 European Respiratory Society International Congress.
WINREVAIR is a novel therapy developed by Merck to treat PAH, a condition characterized by high blood pressure in the arteries between the heart and the lungs. The drug is administered via subcutaneous injection.
