The U.S. Food and Drug Administration (FDA) approved a label update for Winrevair. Bristol Myers Squibb and Merck jointly market Winrevair, a treatment for pulmonary arterial hypertension (PAH). The update incorporates data from the Phase 3 HYPERION trial. This trial evaluated the drug's use in adults newly diagnosed with PAH.
The HYPERION study demonstrated Winrevair significantly reduced the risk of clinical worsening events. The reduction was 76% compared to a placebo. This occurred when Winrevair was added to existing background therapy in recently diagnosed patients. This new data provides evidence for using Winrevair earlier in a patient's treatment journey. This specifically applies within the first year of diagnosis. The update also includes additional safety information.