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US FDA Approves Merck’s Winrevair for Rare Lung Condition

The U.S. Food and Drug Administration’s recent approval of Merck’s (MRK.N) treatment for adults suffering from high blood pressure due to constriction of lung arteries marks a significant milestone for the pharmaceutical giant. The therapy, named Winrevair, represents another potential blockbuster addition to Merck’s expanding portfolio, eliciting a positive market response with shares surging over 4% in extended trading.

Winrevair, now approved for treating pulmonary arterial hypertension (PAH), addresses a condition affecting approximately 40,000 individuals in the United States. Jannie Oosthuizen, president of Merck’s U.S. Human Health business, highlighted the urgent need for effective treatments in this space, noting the high mortality rate associated with PAH.

With a list price of $14,000 per vial, and most patients expected to utilize a single vial every three weeks, the annual cost is estimated at $238,000 per patient. Merck aims to swiftly bring Winrevair to market, anticipating availability by the end of April. The drug was acquired through Merck’s $11.5 billion acquisition of Acceleron Pharma in 2021, part of its strategic diversification into cardiovascular drugs to mitigate potential revenue declines from biosimilar competition to its cancer treatment, Keytruda.

Winrevair, chemically known as sotatercept, is the first of its class to secure FDA approval, targeting activin proteins. PAH, characterized by lung artery constriction, results in elevated blood pressure and debilitating symptoms such as shortness of breath and chest pain, ultimately leading to heart failure.

Analysts anticipate a robust launch for sotatercept, foreseeing it as a pivotal component of standard care for eligible PAH patients. J.P. Morgan analyst Chris Schott predicts peak sales for the therapy to reach approximately $5 billion by 2030.

The FDA’s approval was based on promising results from a 24-week late-stage trial involving 323 PAH patients. Participants treated with Winrevair exhibited significant improvements in exercise capacity, as evidenced by a notable increase in their 6-minute walking distance compared to the placebo group, showcasing the drug’s efficacy in addressing the debilitating symptoms of PAH and potentially improving patients’ quality of life.


Joan David-Leonhard

Joan David Leonhard is a recent Pharm.D graduate with a strong passion for the pharmaceutical industry and a particular interest in pharmaceutical media and communication. Her brief internship experience includes roles in pharmacy where she built strong patient-pharmacist relationships and a pharmaceutical media internship where she actively contributed to drug information articles, blog posts, social media engagement, and various media projects.
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