FDA Approves Label Update for Merck's Winrevair with New PAH Data

The US Food and Drug Administration (FDA) approved an update to the label for Merck & Co.'s Winrevair (sotatercept-csrk), an activin signalling inhibitor, adding efficacy and safety data from the Phase 3 HYPERION trial.

Winrevair is already approved for adults with pulmonary arterial hypertension (PAH) to improve exercise capacity, WHO functional class, and reduce the risk of clinical worsening events, including hospitalisation, lung transplantation, and death.

The label update adds data from adults newly diagnosed with PAH within the past 12 months (WHO functional class II or III) at intermediate-to-high risk of progression, providing evidence for the use of Winrevair earlier in the treatment journey when added to background therapy.