Merck Shares Surge Nearly 5% After FDA Approves Sotatercept (Winrevair) for Pulmonary Arterial Hypertension

The U.S. Food and Drug Administration (FDA) has approvedMSD(MRK.US) The sotatercept, under Merck & Co., Inc. for the treatment of pulmonary arterial hypertension (PAH) — a rare lung disease, will subsequently be branded as Winrevair. Boosted by this news, Merck & Co., Inc. rose nearly 5% in after-hours trading on the U.S. stock market as of press time Tuesday.

Reportedly, without insurance, the drug costs $14,000 per vial, with the vast majority of patients taking one vial every three weeks, amounting to approximately $242,000 annually.

It is reported that MSD acquired the investigational therapy sotatercept in its $11.5 billion acquisition of Acceleron Pharma in 2021. In March last year, a Phase 3 clinical trial showed that adding the experimental therapy sotatercept to stable background treatment significantly improved exercise capacity in patients with pulmonary arterial hypertension (PAH). Trial data showed that in patients with pulmonary arterial hypertension (PAH), sotatercept increased the 6-minute walk distance (6MWD) by 40.8 meters from baseline after 24 weeks of treatment, meeting the primary endpoint of the trial.

Data show that pulmonary arterial hypertension (PAH) is a rare progressive vascular disease, characterized by pulmonary vascular remodeling and cell proliferation, leading to pulmonary hypertension and progressive right ventricular dysfunction. Patients have a poor long-term prognosis, with a 5-year survival rate of approximately 57%. Despite standard treatments, there remains a significant unmet clinical need for PAH, underscoring the urgent demand for new therapeutic options.

Moreover, affected by the approval of Merck & Co., Inc.'s sotatercept, United Therapeutics (UTHR.US) fell more than 5% during after-hours trading on Tuesday in the U.S., as the approval of sotatercept may impact the sales of United Therapeutics' Tyvaso and Remodulin, which are also used for treating pulmonary arterial hypertension.

Editorial Responsibility: Yu Jian SF069