Merck’s PAH drug Winrevair gains FDA approval

In what is seen as an important win for Merck & Co’s (NYSE: MRK), the US pharma giant late yesterday announced that the US Food and Drug Administration (FDA) has approved sotatercept-csrk injection (which will be marketed in the USA as Winrevair).

Merck’s shares rose almost 5% to $131.49 in after-hours trading on Tuesday following the news.

The drug is authorized for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events. Winrevair was previously granted Breakthrough Therapy designation by the FDA.