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FDA approves Merck drug for rare, deadly lung disease

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The Food and Drug Administration on Tuesday approved a drug Merck designed to treat a progressive and life-threatening lung disease, representing a victory for both the drugmaker and patients suffering from this rare disease.

The agency gave the green light to the treatment, which will be marketed under the name Winrevair, intended for adults with pulmonary arterial hypertension. The decision is an important milestone for the approximately 40,000 people living with the disease in the United States, as Winrevair is the first drug to target the root cause of the disease. Other medications available only help manage symptoms.

The condition refers to the narrowing of the small blood vessels in the lungs. This leads to high blood pressure in the arteries that carry blood from the heart to the lungs, which can damage the heart and lead to limited physical activity. From diagnosis, the patient mortality rate is 43% at five years, according to Merck.

Merck estimates Winrevair will be available in select specialty pharmacies in the United States by the end of April, according to a company statement. The medication is an injection given every three weeks and is distributed in one- or two-vial kits.

The price of the vial will be $14,000 before insurance, a Merck spokesperson said in a statement. But the company has a program that offers eligible patients help covering fees and copays.

Winrevair is intended for use with existing therapies to increase exercise capacity, reduce the severity of PAH, and reduce the risk of the disease getting worse.

The approval is key for Merck, which is working to diversify its revenue streams as its top-selling cancer immunotherapy, Keytruda, approaches a loss of market exclusivity in 2028.

In a note released this month, JPMorgan analyst Chris Schott estimates that Winrevair will reach global annual revenues of around $5 billion by 2030 and become one of the “largest growth engines » from Merck.

Merck Chief Medical Officer Eliav Barr told CNBC that “this is a very big opportunity for the company, but really, more importantly, a big, important opportunity for patients.” He noted that the drug would be a “paradigm shift” for PAH patients.

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

The FDA’s approval is based on data from a late-stage trial, which followed more than 300 patients with moderate-stage PAH who were already taking another drug for the blood vessel condition.

The study found that Winrevair When combined with an existing treatment, it helped patients with the disease walk about 40.8 meters further in six minutes than those given a placebo, 24 weeks after the trial began.

“There’s a tremendous improvement in people’s ability to exercise and move around,” Barr said. “Because this disease forces people to stay very, very confined at home. They are out of breath, they can’t move.”

Winrevair in addition to an existing drug also significantly improved eight of the study’s nine secondary objectives. This includes an 84% reduction in the risk of death or worsening of the disease compared to an existing drug alone.

Severe and severe adverse events were less common in the group of patients who took Winrevair compared to those who received a placebo, according to the trial. The most common side effects included nosebleeds, headaches and rash, among others.

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

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

Merck continues to study Winrevair in further phase two and phase three trials.

These trials include late-stage studies in patients with more advanced PAH and those who are in the first year after diagnosis. Merck said it expects these trials to be completed around 2025 and 2026.

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