Merck gains Singapore approval for Winrevair

The Health Sciences Authority (HSA) of Singapore has approved Merck & Co’s (NYSE: MRK) Winrevair (sotatercept), for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1; Functional Class [FC] II to III) to increase exercise capacity, improve WHO functional class, and delay disease progression.

This will mark the first availability of this therapy in Asia, said Merck, known as MSD outside of the USA and Canada, noting that the HSA’s approval of Winrevair is based on safety and efficacy results from the Phase III STELLAR trial.

Winrevair, which came to Merck through its $11.5 billion acquisition of Acceleron Pharma in 2021, was authorized by the US Food and Drug Administration (FDA) in March this year and by the European Commission in August.