Sotatercept (brand name: Winrevair), when added to standard-of-care therapy for severe pulmonary hypertension (PH), significantly decreased the likelihood of worsening disease when added within the first year after diagnosis.
This is according to final phase 3 HYPERION clinical trial results presented at the 2025 European Respiratory Society Congress in Amsterdam. The study, “Sotatercept for Pulmonary Arterial Hypertension Within the First Year of Diagnosis,” was published in the New England Journal of Medicine.
Patients who added sotatercept to their treatment plan within one year of diagnosis reduced the risk of experiencing deterioration in health, such as worsening symptoms, less ability to exercise and unplanned hospitalizations, by 76%.
Researchers ended the HYPERION study ahead of schedule in early 2025 after receiving overwhelmingly positive results for patients after only three doses of the injectable medication.
“These results are incredibly promising for patients early in their journey with pulmonary arterial hypertension, which still has limited treatment options,” said first author and lead investigator Vallerie V. McLaughlin, MD, in a university press release.
Dr. McLaughlin is the Kim A. Eagle Endowed Professor of Cardiovascular Medicine at University of Michigan Medical School and director of the Pulmonary Hypertension Program at the U-M Health Frankel Cardiovascular Center.
“Our findings suggest early treatment with sotatercept may help patients to achieve and maintain a lower risk status and improve outcomes,” she said.
Sotatercept is approved by the U.S. Food and Drug Administration (FDA) for treatment of adults with pulmonary arterial hypertension (PAH) and is offered in combination with standard-of-care therapies. The biologic drug offers a novel approach by targeting proteins called activins, which, when elevated, can thicken the pulmonary arteries and put extra work on the heart to pump blood to the lungs.
The HYPERION study followed prior successful clinical trials, including STELLAR and ZENITH.
Less 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.
