US FDA approves Merck’s therapy for rare lung condition

GHealth News – The U.S. Food and Drug Administration on Tuesday approved Merck’s (MRK.N), opens new tab treatment for adults with high blood pressure due to constriction of lung arteries, adding another potential blockbuster drug to the pharmaceutical giant’s portfolio.

Shares of Merck were up more than 4% in extended trading.

The therapy, branded Winrevair, is approved for treating pulmonary arterial hypertension (PAH), which affects about 40,000 people in the United States.

“We look forward to making a significant difference for these patients that are left with a disease where the five year mortality is 43%,” Jannie Oosthuizen, president of Merck’s U.S. Human Health business, told Reuters.

Winrevair will carry 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 translate to $238,000 per year.

The drugmaker expects to be able to bring the drug to the market by the end of April.

Merck received the rights to Winrevair as part of its $11.5 billion acquisition of Acceleron Pharma in 2021. It has been beefing up its portfolio of cardiovascular drugs as part of its strategy to counter a possible hit to sales to its cancer treatment Keytruda, the world’s top selling medicine, from biosimilars later in the decade.

Winrevair, chemically known as sotatercept, becomes the first treatment to secure FDA approval from its class of drugs, which target a type of protein called activin.

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

The hypertension also makes the heart work harder to pump blood, eventually causing heart failure.

Source: Reuters