The Food and Drug Administration has approved pharma giant Merck’s drug to treat a rare and sometimes deadly lung condition, Merck and the agency said Tuesday.
The FDA approved the drug, called sotatercept-csrk but marketed as Winrevair, to treat adults suffering from pulmonary arterial hypertension, or PAH. About 40,000 people in the U.S. live with the disease, Merck has said. Winrevair will be the first drug to treat the underlying cause of the disease instead of just managing its symptoms, CNBC reports.
Merck bought the company developing the drug, Acceleron Pharma, for $11.5 billion in 2021.
“Pulmonary arterial hypertension is a rare, progressive and ultimately life-threatening disease in which blood vessels in the lungs thicken and narrow, causing significant strain on the heart,” Dr. Marc Humbert, a professor of medicine and director of the Pulmonary Hypertension Reference Center at the Université Paris-Saclay who participated in the phase 3 study of the drug, said in a statement from Merck on Tuesday.
“This approval is an important milestone,” he added, “as it offers healthcare providers a novel therapeutic option that targets a new PAH treatment pathway.”
Merck stock was up almost 5% in after-hours trading on Tuesday. The stock is up almost 11% so far this year.
Patients will be given Winrevair once every three weeks by injection, Merck said. The company said the drug would be available in some specialty pharmacies by the end of next month.
“PAH remains a debilitating disease with high morbidity and mortality,” Dr. Eliav Barr, Merck’s senior vice president and head of global clinical development, said in a statement. “This approval of Winrevair is an important milestone and a testament to our science-led strategy and focus on the development of innovations that can help people affected by rare diseases like PAH. We are proud to bring this novel medicine to patients.”
Merck earlier this year reported a loss of $1.23 billion in its fourth quarter, results that nevertheless beat Wall Street’s expectations.