The Food and Drug Administration on Tuesday approved a drug from Merck designed to treat a progressive and life-threatening lung condition in a win for both the drugmaker and for patients suffering from the rare disease.
The agency greenlighted the therapy, which will be marketed as Winrevair, for adults with pulmonary arterial hypertension. The decision is a big step for the roughly 40,000 people in the U.S. living with that disease because Winrevair is the first drug to target the root cause of the condition. Other available medicines only help manage symptoms.
The condition refers to when the small blood vessels in the lungs narrow. That leads to high blood pressure in the arteries that carry blood from the heart to the lungs, which can damage the heart and result in limited physical activity. Starting from diagnosis, the mortality rate of patients is 43% by five years, according to Merck.
Merck estimates that Winrevair will be available in select specialty pharmacies in the U.S. by the end of April, according to a company release. The drug is an injection administered every three weeks and is distributed in single-vial or double-vial kits.
It will priced at $14,000 per vial before insurance, a Merck spokesperson said in a statement. But the company has a program that offers eligible patients help with out-of-pocket costs and copays.
Winrevair is meant to be used along with existing therapies for the condition to increase exercise capacity, lessen the severity of PAH and reduce the risk of the disease worsening.
The approval is critical for Merck, which is working to diversify its revenue stream as its top-selling cancer immunotherapy Keytruda approaches a loss of market exclusivity in 2028.
In a note this month, JPMorgan analyst Chris Schott estimated that Winrevair would reach worldwide annual sales of around $5 billion by 2030 and emerge as one of Merck’s “largest growth drivers.”
Merck Chief Medical Officer Eliav Barr told CNBC that “this is a really great…
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