CHMP nod adds to momentum for Merck & Co.'s newly-approved Winrevair
28 Jun 2024
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.
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.
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