The US Food and Drug Administration (FDA) has granted Merck, Sharp & Dohme (MSD; NYSE: MRK) regulatory approval for Winrevair (sotatercept), marking it as the first activin signaling inhibitor for the treatment of pulmonary arterial hypertension (PAH) in adults. This milestone concludes a review process under the breakthrough therapy designation (BTD) and is supported by Phase III clinical trial data, which demonstrated that the addition of the subcutaneous injection to standard PAH therapy significantly increased the six-minute walk distance and reduced the risk of death compared to placebo plus background therapy.
MSD plans to launch Winrevair in the US market next month, offering a new treatment option for patients suffering from PAH and potentially transforming the treatment landscape for this condition.- Flcube.com
