FDA Updates Label for Merck's PAH Drug After Promising Trial Results

Merck's drug WINREVAIR (sotatercept-csrk) has received an updated label from the U.S. FDA after a Phase 3 trial showed it reduced the risk of clinical worsening events by 76% in adults with pulmonary arterial hypertension.

The HYPERION study, which included 320 patients, found that adding WINREVAIR to background therapy significantly improved outcomes for those recently diagnosed with PAH.

According to Dr. Vallerie McLaughlin, 'The results of HYPERION provide evidence for the use of WINREVAIR in adults diagnosed with PAH within the previous year who were receiving background therapy.'