'Sotatercept slashes death risk by 76% in pulmonary arterial hypertension'

Early combination therapy with sotatercept (sold as Winrevair) has been confirmed to cut the risk of death in pulmonary arterial hypertension (PAH) patients by up to 76 percent.

Sotatercept is the first activin signaling inhibitor (ASI) shown to suppress abnormal vascular proliferation and improve vascular structure. Clinical trials demonstrated improvements in nine indicators, including six-minute walk distance, in patients treated for an average of over nine months after diagnosis.

Professor Kim Dae-hee of the Department of Cardiology at Asan Medical Center explained that the sotatercept group reduced the risk of clinical worsening or death by 76 percent compared to the placebo group at a median follow-up of 13.2 months in a phase 3 clinical trial conducted on patients with pulmonary arterial hypertension diagnosed less than one year ago.

He spoke at an MSD Korea symposium held just before sotatercept's launch.

“This clinical study was terminated early based on the recommendation of the Independent Data Monitoring Committee, which found that continuing the placebo group was ethically inappropriate due to the significant therapeutic effect of Winrevair,” Professor Kim said. “Given the high proportion of patients receiving dual combination therapy at baseline in this clinical trial compared to the approved clinical study, this provides evidence supporting the active use of the drug in combination therapy from the early stages of diagnosis.”

This is expected to lead to a paradigm shift in the treatment of pulmonary arterial hypertension, Professor Kim added.

Professor Choi Jung-hyun of Pusan National University Hospital noted that, in the study, 143 patients originally assigned to the placebo group were switched to the Winrevair group among the total of 426 adults with pulmonary arterial hypertension.

“Long-term follow-up data are expected to provide richer evidence regarding the benefits and risks,” Professor Choi explained. “This interim analysis confirmed a positive benefit-risk profile for the addition of Winrevair therapy in adult pulmonary arterial hypertension patients.”

Professor Chung Wook-jin of the Department of Cardiology at Gachon University Gil Medical Center (and President of the Korean Pulmonary Hypertension Society), who chaired the symposium, stated, “Thanks to the research and efforts of pulmonary arterial hypertension specialists, diagnosis and survival rates are improving, clinical guidelines tailored to the characteristics of the domestic healthcare environment are being established, and the treatment landscape is changing.”

Professor Chung added that improving the treatment environment to enable early access to new drugs is essential for delivering patient benefits.

Myeong Hye-jin, Executive Director of MSD Korea's Pharma Business Division, stated, “Having opened new possibilities for PAH treatment with Winrevair, MSD Korea will continue striving to improve the PAH treatment environment and enhance patients' access to innovative therapies.”