Merck Places Great Hopes on a New Drug Against a Potentially Fatal Lung Disease Approved on Tuesday in the USA
Merck is pinning substantial hopes on a newly approved drug designed to combat a potentially fatal lung condition, which received approval on Tuesday in the United States. The company is optimistic that the medication, named Winrevair, which treats a condition known as pulmonary arterial hypertension (PAH) affecting nearly 40,000 people in the USA, will pave the way to counter a significant decline in revenue later this decade. In 2021, Merck paid $11.5 billion for the company that developed the drug. Some analysts estimate the revenues could reach up to $7.5 billion per year.
Merck Banks on This Blockbuster Success, as More Than 40% of the Company's Revenue, Last Year About 25 Billion Dollars, Comes from the Cancer Treatment Keytruda, the World's Best-Selling Drug. Merck's Main Patent in the US for Keytruda Expires in 2028, Clearing the Way for More Cost-Effective Versions That Could Cut Into Sales.
Winrevair Offered at a Price of $14,000 per Vial, Which Equals the Quantity Administered Every Three Weeks for About Two-Thirds of Patients. This Amounts to About $242,000 for a Full Year, Although Merck Said That Costs Would Vary Depending on the Patient as Dosage is Weight-Dependent. "We See This as an Opportunity with Potential Worth Several Billion Dollars for the Company," Merck CEO Rob Davis Said in an Interview.
"Over time, we believe we can penetrate into earlier lines of therapy and potentially into much broader patient populations." Davis said that progress in Merck's research pipeline would help to make the loss of Keytruda's exclusivity "more of a hill than a cliff. And our confidence that we can grow beyond that is high."
The U.S. Food and Drug Administration has approved Winrevair as an add-on therapy to other medications for pulmonary arterial hypertension, commonly known as PAH. The disease is a type of high blood pressure caused by narrowing of the small arteries in the lungs. It leads to shortness of breath and fatigue, reduces endurance, and can be fatal if left untreated. It occurs most frequently in women aged 30 to 60.
Winrevair, also known by its generic name Sotatercept, employs a new approach to combat the underlying cause of PAH. It works by stopping the proliferation of cells in the arterial walls that cause narrowing. In a Phase 3 study, a Sotatercept injection every three weeks significantly improved the volunteers' exercise capacity – measured by the distance covered in six minutes – and extended the time to death or disease progression compared to a placebo.
"It's a major breakthrough," said Dr. Jessica Huston, a cardiologist at Ascension Saint Thomas Heart in Nashville, Tennessee, who has enrolled patients in the study funded by Merck. "It feels like this drug is finally something different from what we have been doing all the time, and it is actually disease-modifying."
The medication has been associated with side effects such as bleeding and the formation of small blood vessels on the skin in some patients. Its launch brings cardiovascular treatment back to the forefront for Merck, based in Rahway, New Jersey. The company's first billion-dollar drug was Vasotec for high blood pressure. Mevacor was the first commercial statin for high
