Injectable Drug Slows Deterioration From Pulmonary Hypertension

MONDAY, Oct. 6, 2025 (HealthDay News) — A recently approved injectable drug can significantly stall deteriorating health among people newly diagnosed with the most severe form of high blood pressure, a new study says.

Sotatercept reduced patient’s risk of deterioration by 76% due to pulmonary hypertension, or high blood pressure in the heart-to-lung system, researchers reported recently in the New England Journal of Medicine.

Patients treated with sotarecept within the first year after diagnosis proved more likely to maintain their exercise regimen, ward off worsening symptoms and avoid unplanned hospitalizations, results showed.

“These results are incredibly promising for patients early in their journey with pulmonary arterial hypertension, which still has limited treatment options,” lead researcher Dr. Vallerie McLaughlin, a professor of cardiovascular medicine at University of Michigan Medical School, said in a news release.

In fact, the clinical trial concluded early because results were so positive the research team felt they couldn’t ethically continue to allow randomly selected patients to keep taking placebo.

The U.S. Food and Drug Administration (FDA) approved sotatercept in March 2024 for treatment of pulmonary hypertension, according to the drug’s maker Merck. The drug is sold under the brand name Winrevair.

A biologic drug, sotatercept works by targeting proteins called activins. Elevated activin signaling can lead to thicker arteries in the lungs, which in turn makes the heart work harder to pump blood through them, researchers explained.

For the trial, researchers recruited 320 patients with pulmonary hypertension and randomly assigned them to receive an injection of either sotatercept or placebo every 21 days.

Positive results for sotatercept patients started to accrue after just three doses of the drug, researchers said.

After an average follow-up of 12 months, just under 11% of sotatercept patients had experienced a clinical worsening of their condition, compared with 37% of placebo patients.

For example, about 5% of sotatercept patients had a deterioration in their ability to exercise, compared to 29% of placebo patients, results showed.

Likewise, unplanned hospitalizations occurred among 2% of sotatercept patients versus 9% of those on placebo.

“Our findings suggest early treatment with sotatercept may help patients to achieve and maintain a lower risk status and improve outcomes,” McLaughlin said.

The most common side effects reported were nosebleeds and spider veins, researchers said.

“The positive effects of adding sotatercept to standard therapy in patients with PAH are remarkable,” said researcher Dr. Victor Moles, a clinical associate professor of internal medicine-cardiology at the University of Michigan Medical School.

The results “underscore the critical importance of early intervention, demonstrating that earlier treatment leads to better outcomes,” Moles said in a news release.

Merck funded the clinical trial.

The drug is expensive. A 45 to 60 mg vial costs about $14,516, according to Drugs.com. In this trial, patients had a target dose of 0.7 mg per kilogram of body weight.

More information

The American Heart Association has more on pulmonary hypertension.

SOURCES: University of Michigan, news release, Sept. 30, 2025; New England Journal of Medicine, Sept. 30, 2025

What This Means For You

Patients with pulmonary hypertension should ask their doctor if sotatercept might help them.