Merck & Co. received the approval by the FDA for a new treatment of a rare and dangerous form of high blood pressure, pulmonary arterial hypertension. Analysts expect the drug to reach record sales, as older drugs begin fading later this decade.
Potential game changer in the treatment of pulmonary hypertension
This new drug will help fill the gap for some 40,000 Americans with pulmonary arterial hypertension. It is a dangerous increase in blood pressure in the lungs. There are a number of therapies available in practice now. However, some patients don’t respond fully to them. The drug is approved to be used alongside these therapies.
The drug has the global trade name sotatercept. In the US, they will sell it as Winrevair, according to information posted on the Food and Drug Administration website.
Doctors said Merck’s drug can potentially change their approach to pulmonary arterial hypertension (PAH) treatment. Dr. Carlos Santos-Gallego, a cardiologist at the Icahn School of Medicine at Mount Sinai, said. “This is potentially a groundbreaking therapy for PAH.”
The FDA approved the drug for self-administration. It means that patients can take it at home rather than going to a doctor’s office.
Economics behind
This new medical drug, Winrevair, is the first new treatment available for PAH in almost a decade. Merck acquired it in the $11 billion acquisition of Acceleron Pharma.
Jefferies analysts estimate peak annual sales at $7.5 billion, while the average of analysts surveyed by Bloomberg is about $4.7 billion in 2034. Merck has not given specific sales estimates, but Chief Executive Officer Rob Davis said it’s likely to be a “multibillion dollar drug.”
How this pulmonary hypertension treatment works
Research has linked PAH to abnormal growth in affected blood vessels, leading to constriction and blockage. Merck’s drug interferes with cell-growth signals in the tissue, which may enable doctors to treat the cause of the disease.
“This is the first drug that’s shown potential to be disease modifying opposed to just treating the symptoms,” Davis said. It could potentially benefit an even broader patient population down the line, he said.
Side effects
In trials, the most common side effects were low platelet levels and increased hemoglobin, both of which can be monitored, Santos-Gallego said. Overall, side effects were higher among patients getting a placebo than those on Merck’s drug.
