FDA Gives Green Light to Merck’s Blood Pressure Treatment, Reuters Reports

FDA Gives Green Light to Merck’s Blood Pressure Treatment, Reuters Reports

By Leroy Léo and Michael Erman

(Reuters) – The U.S. Food and Drug Administration on Tuesday approved Merck’s treatment for adults with high blood pressure caused by 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 treatment, called Winrevair, is approved for the treatment of 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 who are left with a disease where the five-year mortality is 43%,” Jannie Oosthuizen, president of Merck’s U.S. human health division, told Reuters.

Winrevair will have a list price of $14,000 per vial, Oosthuizen said. According to data from the company’s trial, most patients will use a single vial every three weeks, which would cost $238,000 per year.

The drugmaker hopes to have its drug on the market by the end of April.

Merck received the rights to Winrevair as part of its acquisition of Acceleron Pharma (NASDAQ:) for $11.5 billion in 2021. The company has strengthened its cardiovascular drug portfolio as part of its strategy to counter a possible drop in sales of its cancer treatment Keytruda. , the world’s best-selling drug, biosimilars later in the decade.

Winrevair becomes the first treatment to gain FDA approval for its class of drugs, which target a type of protein called activin, which leads to higher levels of a follicle-stimulating hormone associated with the disease.

It is the second drug to be approved for PAH in less than a week, following Johnson & Johnson’s (NYSE:) Opsynvi – a combination of J&J’s former PAH drug Opsumit and generic drug tadalafil – which received FDA approval Friday evening.

PAH is caused by constriction of the arteries in the lungs, leading to high blood pressure and symptoms such as shortness of breath, chest pain and dizziness.

High blood pressure also makes the heart work harder to pump blood, eventually causing heart failure.

In October, JP Morgan analyst Chris Schott estimated the therapy would reach peak sales of between $3 billion and $4 billion.

Approval of Merck’s drug was based on a 24-week late-stage trial in 323 PAH patients.

In the trial, patients treated with the drug showed significant improvement in their exercise capacity, increasing their 6-minute walk distance by 40.8 meters, compared to placebo.

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