Sotatercept receives strong recommendation in updated PAH guidelines

Sotatercept, marketed as Winlevair, has received a ‘Strong Recommendation’ in the updated pulmonary arterial hypertension (PAH) guidelines from the European Society of Cardiology and the European Respiratory Society (ESC/ERS). The recommendation applies to patients categorized as intermediate-low risk, intermediate-high risk, and high risk.

As the first-in-class activin signaling inhibitor, sotatercept targets vascular proliferation signals to potentially reverse thickened vessel walls and deformed pulmonary vascular structures. The ESC/ERS guidelines were updated four years earlier than planned to reflect the evolving treatment landscape and the clinical evidence accumulated since the 2022 guidelines.

The clinical committee assigned the drug a ‘high certainty of evidence’ rating based on results from four randomized controlled trials: PULSAR, STELLAR, ZENITH, and HYPERION. These studies demonstrated consistent benefits in key clinical endpoints, including 6-minute walk distance, NT-proBNP levels, hospitalization rates, and time to clinical worsening.

This update introduces a new therapeutic pathway—activin signaling inhibition—to the existing three vasodilatory mechanisms, expanding treatment options through combination therapies. In South Korea, MSD Korea is working to improve patient access through initiatives such as the ‘Rapid Listing Pilot Project for Rare Disease Treatments’ following the drug's approval by the Ministry of Food and Drug Safety.