Leroy Leo and Michael Erman
(Reuters) – The U.S. Food and Drug Administration on Tuesday approved a Merck drug to treat adults with high blood pressure due to narrowing of the pulmonary arteries, adding another potential blockbuster drug to the pharmaceutical giant’s portfolio.
Merck shares rose more than 4% in extended trading.
The therapy, under the brand name Winrevair, is approved to treat pulmonary arterial hypertension (PAH), which affects approximately 40,000 people in the United States.
“We look forward to making a significant difference for these patients who are left with a disease that has a five-year mortality rate of 43%,” Jenny Oosthuizen, president of Merck’s U.S. healthcare business, told Reuters.
Winrevair’s list price will be $14,000 per bottle, Oosthuizen said. Most patients would use one bottle every three weeks, which would cost $238,000 per year, according to the company’s research.
The manufacturer expects to be able to bring the drug to market by the end of April.
Merck acquired the rights to Winrevair as part of its $11.5 billion acquisition of Acceleron Pharma (NASDAQ:) in 2021. The company is expanding its portfolio of cardiovascular drugs as part of its strategy to counter a potential hit to sales of its cancer treatment Keytruma. , the world’s best-selling drug, from biosimilars at the end of the decade.
Winrevair, chemically known as sotatercept, becomes the first drug to receive FDA approval from its class of drugs that target a type of protein called activin that leads to increased levels of follicle-stimulating hormone, which is associated with the disease.
PAH is caused by narrowing of the arteries in the lungs, leading to high blood pressure and symptoms such as shortness of breath, chest pain and dizziness.
Hypertension also causes the heart to work harder to pump blood, eventually leading to heart failure.
“We see sotatercept launching well early on and quickly becoming part of the standard of care for eligible patients with PAH,” JP Morgan analyst Chris Schott (ETR:) wrote in a note.
Schott estimates the therapy will reach approximately $5 billion in sales by 2030.
Merck’s approval was based on results from a 24-week late-stage study of 323 patients with PAH.
In the study, patients taking the drug showed significant improvements in exercise capacity, increasing their 6-minute walking distance by 40.8 meters compared to the placebo group.