CHMP nod adds to momentum for Merck & Co.'s newly-approved Winrevair

2024-06-28

临床3期临床结果上市批准

Three months after scoring FDA approval, Merck & Co.'s pulmonary arterial hypertension (PAH) treatment Winrevair (sotatercept) is a step closer to doing the same in Europe after the bloc's drug advisory body adopted a positive opinion on the company's marketing application Friday.

Winrevair, the first activin signaling inhibitor therapy for PAH, is recommended for use in combination with other PAH therapies in adult patients with WHO Functional Class II to III, to improve exercise capacity.

The recommendation by the Committee for Medicinal Products for Human Use (CHMP) is based on data from the Phase III STELLAR trial, which showed that adding Winrevair to existing therapy significantly improved exercise capacity, measured by the six-minute walk distance (6MWD). Patients on Winrevair walked an average of 40.8m farther at 24 weeks than those on placebo. The drug also reduced the risk of death or PAH clinical worsening events by 84%, a secondary outcome that sets it apart from existing therapies.

More to follow.

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