PAH drug Winrevair may be prescribed at general hospitals in Korea

Passes drug committee reviews at SMC, SNUH, etc.

Selected for the 2nd Approval-Evaluation-Negotiation Pilot Program…reimbursement listing process underway

The new pulmonary arterial hypertension (PAH) drug Winrevair is beginning to gain prescribing access at major hospitals in Korea.

According to industry sources, MSD Korea’s activin signaling inhibitor (ASI) Winrevair (sotatercept has passed the drug committee (DC) reviews at leading tertiary hospitals, including Samsung Medical Center and Seoul National University Hospital.

At the same time, MSD is currently conducting landing procedures at about 20 major medical institutions nationwide.

Winrevair is a first-in-class innovative drug with a new mechanism of action, emerging 20 years after sildenafil, which targets the NO–sGC–cGMP pathway, was introduced in 2005. The drug is currently selected for the second phase of Korea’s ‘Approval-Evaluation-Negotiation Concurrent Pilot Program’ and is undergoing reimbursement procedures, but no significant progress has been made so far.

Pulmonary arterial hypertension is a particularly challenging area for new drug development. Unlike existing treatments focused on dilating blood vessels, Winrevair improves vascular remodeling, the fundamental cause of the disease.

Consequently, no comparable therapeutic alternative is available. If Winrevair is evaluated within the existing economic assessment framework, it would be compared to treatments developed two decades ago. This situation naturally delays the listing process. This challenge is not unique to Winrevair but is one commonly faced by drugs included in the parallel pilot program. Nearly 200 days have already passed since Winrevair received approval from Korea’s Ministry of Food and Drug Safety.

Therefore, attention is now focused on whether Winrevair will successfully complete the reimbursement listing process and ultimately establish itself as a treatment option for patients.

Winrevair received regulatory approval based on the STELLAR clinical trial. This study evaluated the efficacy and safety of Winrevair in 323 adult patients with pulmonary arterial hypertension (PAH) classified as WHO functional class (WHO-FC) II or III. During the 24-week study period, patients received Winrevair or a placebo in combination with their existing therapy once every three weeks.

Results showed that Winrevair increased the 6-minute walk distance by 40.8 meters (Hodges–Lehmann estimate) compared with placebo at Week 24. It also reduced the risk of clinical worsening or death by 84%.

In addition, significant improvements were observed across 8 secondary endpoints, including WHO-FC, pulmonary vascular resistance (PVR), and the heart failure biomarker NT-proBNP, compared with placebo.

Wook Jin Jeong, President of the Korean Society of Pulmonary Hypertension (Professor of Cardiology at Gachon University Gil Medical Center), said, “Winrevair is a treatment with a new mechanism of action that restores abnormal pulmonary vascular structure toward normal. Based on the latest evidence, updated global clinical guidelines now present it as an option for combination therapy in the early phases of treatment. This approval broadens the treatment options available to pulmonary arterial hypertension patients in Korea.”