The FDA approves Merck's drug sotatercept to deal with a uncommon, deadly lung illness

The Food and Drug Administration approved a drug on Tuesday Merck Designed to treat a progressive and life-threatening lung disease, which is a win for both the drugmaker and patients suffering from the rare disease.

The agency gave the therapy, marketed as Winrevair, the green light for adults with pulmonary arterial hypertension. The decision is a big step for the approximately 40,000 people in the United States living with the disease, as Winrevair is the first drug to target the root cause of the disease. Other medications available only help relieve symptoms.

This disease occurs when the small blood vessels in the lungs narrow. This leads to high blood pressure in the arteries that carry blood from the heart to the lungs, which can lead to heart damage and limited physical activity. According to Merck, the mortality rate for patients after diagnosis is 43% within five years.

According to a company statement, Merck estimates that Winrevair will be available in select specialty pharmacies in the United States by the end of April. The medication is an injection administered every three weeks and is available in single or double vial sets.

The price per vial before insurance will be $14,000, a Merck spokesman said in a statement. But the company has a program that offers eligible patients help with deductibles and copays.

Winrevair is intended to be used alongside existing therapies for the disease to improve exercise performance, reduce the severity of PAH and reduce the risk of the disease getting worse.

The approval is crucial for Merck, which is working to diversify its revenue streams as its top-selling cancer immunotherapy drug Keytruda is on the verge of losing market exclusivity in 2028.

In a note this month, JPMorgan analyst Chris Schott estimated that Winrevair would reach global annual sales of around $5 billion by 2030 and become one of Merck's “biggest growth drivers.”

Eliav Barr, Merck's chief medical officer, told CNBC: “This is a really big opportunity for the company, but really, more importantly, a big, important opportunity for patients.” He noted that the drug will mean a “paradigm shift” for patients with PAH.

The company gained the rights to Winrevair through its $11.5 billion acquisition of Acceleron Pharma in 2021. At the time, Merck estimated the PAH market would be about $7.5 billion by 2026.

The FDA's approval is based on data from a late-stage study that followed more than 300 patients with moderate-stage PAH who were already taking another drug for the blood vessel disease.

The study found that Winrevair When combined with existing therapy, patients with the condition were able to walk about 40.8 meters more in six minutes than those who received a placebo, 24 weeks into the study.

“People's ability to exercise and exercise has improved tremendously,” Barr said. “Because this disease makes people very, very tied to their home. You have shortness of breath and can’t move.”

Winrevair also significantly improved eight of the study's nine secondary objectives, in addition to an existing drug. This includes reducing the risk of death or worsening of the disease by 84% compared to a conventional drug alone.

According to the study, serious and serious adverse events occurred less frequently in the group of patients who took Winrevair than in those who received a placebo. Some of the more common side effects included nosebleeds, headaches and skin rashes.

A notable advantage of Winrevair is that patients or caregivers can inject it under the skin with appropriate training from a healthcare provider. Meanwhile, some existing treatments for PAH must be administered by healthcare professionals in an infusion center.

“One of the things we heard very loud and clear from both patients and doctors was that they wanted something you could get.” at home,” Barr said.

Merck continues to investigate Winrevair in other phase 2 and phase 3 studies.

These studies include late-stage studies in patients with more advanced PAH disease and those within the first year of diagnosis. Merck has announced that these studies will be completed in approximately 2025 and 2026.

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