Singapore HSA Approves MSD's Winrevair (sotatercept) for Pulmonary Arterial Hypertension
核心洞察
The Health Sciences Authority (HSA) of Singapore has approved Winrevair (sotatercept) for adults with pulmonary arterial hypertension (搜索) (PAH (搜索)).
Winrevair is the first activin (搜索) signaling inhibitor approved in Asia for PAH (搜索), marking a significant advancement in treatment options.
The approval is based on the Phase 3 STELLAR trial, which demonstrated improved exercise capacity and reduced risk of clinical worsening.
MSD (Merck & Co. (搜索), Inc.) has received approval from the Health Sciences Authority (HSA) of Singapore for Winrevair (sotatercept) for the treatment of adults with pulmonary arterial hypertension (搜索) (PAH (搜索), World Health Organization [WHO] Group 1; Functional Class [FC] II to III). This approval marks the first availability of this therapy in Asia.
The approval is based on the Phase 3 STELLAR trial, a pivotal study that demonstrated the efficacy and safety of sotatercept in improving exercise capacity, WHO functional class, and delaying disease progression in PAH (搜索) patients. PAH is a rare, progressive, and life-threatening disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation.
Clinical Efficacy and Safety
The Phase 3 STELLAR trial (NCT04576988) was a randomized, double-blind, placebo-controlled, multicenter study evaluating sotatercept as an add-on to background therapy in adults with PAH (搜索). The primary endpoint was the change in six-minute walk distance (6MWD) at Week 24. Key secondary endpoints included changes in pulmonary vascular resistance (PVR), N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels, WHO functional class, and time to death or clinical worsening events.
Results from the STELLAR trial showed that adding Winrevair to background therapy increased the six-minute walk distance from baseline by 41 meters at Week 24. Furthermore, it significantly reduced the risk of death from any cause or PAH (搜索) clinical worsening events by 84% compared to background therapy alone. Winrevair is administered once every three weeks via subcutaneous injection and is intended for use under the guidance of a healthcare professional. Patients or caregivers may administer the injection when deemed appropriate and after receiving proper training and follow-up from their doctor.
Mechanism of Action
Winrevair is the first US-FDA-approved activin (搜索) signaling inhibitor therapy for PAH (搜索). It works by improving the balance between pro- and anti-proliferative signaling to regulate vascular cell proliferation, which underlies PAH. This novel mechanism of action offers a different approach to care compared to existing therapies.
Impact on PAH Treatment
"The HSA’s approval of WINREVAIR® provides new hope for PAH (搜索) patients in Singapore and across Asia," said Dr. Abdullahi Sheriff, Managing Director, MSD in Singapore, Malaysia & Brunei. "This approval is a testament to MSD’s commitment to leading-edge science and driving innovation that can help people affected by cardiovascular and rare diseases like PAH."
Dr. Ivan Su, Executive Director, Global Medical & Scientific Affairs Lead for Asia Pacific, MSD, added, "With WINREVAIR®, we are introducing a novel therapy that targets the underlying disease, offering a different approach to care. This is a major step forward in improving both the quality of life and long-term outcomes for patients suffering from this life-threatening condition."
Availability
Winrevair is expected to be available for dispensing by select healthcare providers in Singapore by Q1 2025.