FDA Approves Update to WINREVAIR Label Based on HYPERION Trial Data

The U.S. FDA has approved an update to the label for Merck's WINREVAIR (sotatercept-csrk) injection, allowing it to include data from the Phase 3 HYPERION trial.

In the HYPERION trial, adding WINREVAIR on top of background therapy reduced the risk of clinical worsening events by 76% in adults with PAH compared to placebo.

The study enrolled participants within their first year of diagnosis and included those at intermediate to high risk of disease progression. The results provide evidence for the use of WINREVAIR earlier in the treatment journey, when added to background therapy within the first year following a diagnosis.