By Leroy Leo and Michael Erman
(Reuters) – The U.S. Food and Drug Administration on Tuesday approved Merck’s treatment for adults with high blood pressure due to constriction of the pulmonary arteries, adding another potential blockbuster drug to the pharmaceutical giant’s portfolio.
Merck shares rose more than 5% in extended trading.
The therapy, called Winrevair, is approved to treat pulmonary arterial hypertension (PAH), which affects about 40,000 people in the United States.
“We look forward to making a meaningful difference for these patients suffering from a disease whose five-year mortality is 43%,” Jannie Oosthuizen, president of Merck’s human health division in the United States, told Reuters.
Winrevair will have a list price of $14,000 per vial, Oosthuizen said. According to data from the company’s study, most patients will use a single vial every three weeks, which would translate to $238,000 per year.
The drugmaker expects to be able to bring the drug to market by the end of April.
Merck received the rights to Winrevair as part of its $11.5 billion acquisition of Acceleron Pharma (NASDAQ:) in 2021. It has strengthened its portfolio of cardiovascular drugs as part of its strategy to counter a possible decline in sales of the its cancer treatment Keytruda, the world’s best-selling medicine, from biosimilars later in the decade.
Winrevair becomes the first treatment to win FDA approval for its class of drugs, which target a type of protein called activin that leads to higher levels of a follicle-stimulating hormone associated with the disease.
This is the second drug to be approved for PAH in less than a week, after Johnson & Johnson (NYSE:) Opsynvi, a combination of J&J’s older PAH drug Opsumit and the generic drug tadalafil, received approval FDA approval last Friday.
PAH is caused by a constriction of the pulmonary arteries, leading to increased blood pressure and symptoms such as shortness of breath, chest pain and dizziness.
High blood pressure also makes the heart’s job harder to pump blood, ultimately causing heart failure.
In October, JP Morgan analyst Chris Schott (ETR:) estimated that the therapy would reach peak sales of between $3 billion and $4 billion.
Merck’s approval of the drug was based on a 24-week late-stage study in 323 PAH patients.
In the study, patients treated with the drug showed a significant improvement in exercise capacity, increasing the distance walked in 6 minutes by 40.8 meters, compared to the placebo.