Health Sciences Authority approves pulmonary arterial hypertension treatment
Winrevair is expected to be available by the first quarter of 2025.
The Health Sciences Authority (HSA) has approved Winrevair (sotatercept), developed by Merck & Co. (MSD), for the treatment of adults with pulmonary arterial hypertension (PAH), making it the first therapy of its kind available in Asia.
This approval is based on findings from the Phase 3 STELLAR trial, which demonstrated that adding Winrevair to existing therapies improved patients' six-minute walk distance by 41 metres after 24 weeks. Additionally, the therapy reduced the risk of death from any cause or PAH clinical worsening events by 84% compared to background therapy alone.
PAH is a rare and progressive blood vessel disorder that involves the narrowing of small pulmonary arteries, leading to elevated blood pressure in the lungs. Winrevair works by regulating vascular cell proliferation to address the underlying causes of PAH.
The treatment is administered once every three weeks via subcutaneous injection, either by a healthcare professional or by patients and caregivers with proper training and medical follow-up.
Pulmonary Hypertension Singapore has welcomed the approval and plans to collaborate with MSD to raise awareness of PAH and improve access to therapies like Winrevair.
The treatment is expected to be available through select healthcare providers in Singapore by the first quarter of 2025.