Biologic drug reduces symptoms, hospitalization for severe pulmonary hypertension after diagnosis

Results of the phase 3 clinical trial suggest benefits for early treatment

2025-09-30

(Press-News.org) Prescribing the biologic drug sotatercept alongside standard treatment for the most severe form of pulmonary hypertension significantly reduces the likelihood of worsening disease when added within the first year after diagnosis, according to a study published in the New England Journal of Medicine.

Within the first year of receiving a pulmonary arterial hypertension (PAH) diagnosis, patients who took sotatercept in addition to standard-of-care therapy reduced the risk experiencing deterioration in health — such as less ability to exercise, worsening symptoms and unplanned hospitalizations — by 76%.

Investigators for the phase 3 clinical trial detected positive results for patients after just three doses of the injectable medication, which sold under the brand name Winrevair.

Results were presented at the 2025 European Respiratory Society Congress in Amsterdam.

“These results are incredibly promising for patients early in their journey with pulmonary arterial hypertension, which still has limited treatment options,” said first author Vallerie V. McLaughlin, M.D., the Kim A. Eagle Endowed Professor of Cardiovascular Medicine at University of Michigan Medical School.

McLaughlin, who directs the Pulmonary Hypertension Program at the U-M Health Frankel Cardiovascular Center, was lead investigator of the double-blind, placebo-controlled HYPERION study.

The clinical trial concluded early due to loss of clinical equipoise, meaning researchers felt they could not ethically continue the study due to overwhelmingly positive results for patients on sotatercept compared to placebo in recent sotatercept randomized, controlled trials.

“PAH is a chronic, progressive condition with high morbidity and mortality, and many patients present at advanced stages of disease,” McLaughlin said.

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

Sotatercept is approved by the U.S. Food and Drug Administration for treatment of adults with pulmonary arterial hypertension, or PAH, and is offered in concert with standard-of-care therapies.

The medication offers a novel approach by targeting proteins called activins. In PAH, elevated activin signaling can eventually thicken the pulmonary arteries, putting extra work on the heart to pump blood to the lungs.

Past studies of sotatercept showed benefits for patients with high-risk as well as those with longstanding pulmonary arterial hypertension.

The initial trial, STELLAR, found that patients taking the medication had improved capacity for exercise. The ZENITH trial demonstrated a decreased risk of death, hospitalization and lung transplantation in those at high risk of death.

Patients in both studies had a diagnosis of PAH for an average of seven to eight years. HYPERION extends the evidence base to patients diagnosed within one year.

Fewer than 2% of participants taking sotatercept in the HYPERION trial were hospitalized for worsening PAH symptoms, compared to 8.8% of the placebo group.

The most common adverse events reported with sotatercept were nosebleeds and spider veins.

“The positive effects of adding sotatercept to standard therapy in patients with PAH are remarkable,” said Victor M. Moles, M.D., HYPERION investigator and clinical associate professor of internal medicine-cardiology at U-M Medical School

“The results from the HYPERION trial underscore the critical importance of early intervention, demonstrating that earlier treatment leads to better outcomes.”

Additional authors: For a complete list of HYPERION investigators, view the supplementary appendix.

Funding/disclosures:

This study was funded by Merck Sharp & Dohme, a subsidiary of Merck. The study analyses presented here were funded by Merck Sharp & Dohme, a subsidiary of Merck.

Paper cited: “Sotatercept for Pulmonary Arterial Hypertension within the First Year of Diagnosis,” New England Journal of Medicine. DOI: 10.1056/NEJMoa2508170

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Biologic drug reduces symptoms, hospitalization for severe pulmonary hypertension after diagnosis

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