New Treatment for Rare, Deadly Lung Condition
On Tuesday, the Food and Drug Administration (FDA) approved a novel treatment developed by Merck, Winrevair, aimed at treating a severe and progressive lung disease, marking a significant advancement for both the pharmaceutical company and individuals diagnosed with the rare condition.
Winrevair has been authorized for the treatment of adults with pulmonary arterial hypertension (PAH), a condition affecting roughly 40,000 Americans. This drug stands out as the first to directly tackle the underlying cause of PAH, whereas existing medications have focused on symptom management.
PAH is characterized by the narrowing of small blood vessels in the lungs, leading to elevated blood pressure in the arteries that transport blood from the heart to the lungs. This condition can severely damage the heart and limit physical activity, with a 43% mortality rate within five years of diagnosis, according to data from Merck.
Merck anticipates that Winrevair will be accessible through selected specialty pharmacies in the U.S. by the end of April. The medication, which is administered as an injection every three weeks, will be available in kits containing either one or two vials.
The cost of Winrevair is expected to be set at $14,000 per vial before insurance adjustments, as stated by a Merck representative. However, the company is offering a program to assist eligible patients with their out-of-pocket expenses and copayments.
Designed to be used in conjunction with other treatments for PAH, Winrevair aims to enhance exercise capacity, alleviate the severity of the condition, and lower the risk of disease progression.
This FDA approval is particularly crucial for Merck as it seeks to diversify its revenue sources ahead of the 2028 patent expiration of its best-selling cancer drug, Keytruda.
The approval was based on the results of a late-stage clinical trial involving over 300 PAH patients at a moderate stage of the disease who were already on another treatment for their condition. The trial demonstrated that patients taking Winrevair in addition to their existing therapy could walk approximately 40.8 meters further in six minutes after 24 weeks compared to those on a placebo.
The improvement in mobility and the increased ability to exercise is tremendous, as PAH significantly restricts patients’ physical activities due to symptoms like severe shortness of breath. Moreover, when combined with another medication, Winrevair notably achieved eight out of nine secondary objectives in the study, including an 84% reduction in the risk of death or deterioration of the condition compared to those on an existing treatment alone.