Merck Advances with Winrevair: Positive Phase III Results in Severe Pulmonary Arterial Hypertension (PAH) Study

Study Success:
Merck's Phase III ZENITH study evaluating Winrevair (sotatercept-csrk) in adults with severe pulmonary arterial hypertension (PAH) has met its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the risk of morbidity or mortality[2][4].

Patient Population:
The study focused on PAH patients at functional class III or IV, who are at high risk of mortality from their condition[1].

Clinical Benefit:
Adding Winrevair to background therapy helped patients with severe lung hypertension stay alive and avoid hospitalizations due to worsening PAH[3].

Primary Outcome:
The study's primary composite outcome measure was time to first confirmed morbidity or mortality event, defined as all-cause death, lung transplantation, or hospitalization due to worsening PAH[5].

Regulatory Filings:
Following the positive results, Merck is preparing to submit regulatory filings for Winrevair, aiming to expand its use in treating severe PAH[1].