Sotatercept in Pulmonary Arterial Hypertension – Revolution, Risk, and the Road Ahead

Extract Sotatercept, the first approved activin signalling inhibitor (ASI), represents a major advancement in the treatment of pulmonary arterial hypertension (PAH). Met with substantial enthusiasm from patients, caregivers, and physicians, sotatercept has the potential to refine, perhaps even revolutionize, treatment of PAH. Its novel mechanism of action targets fundamental disease processes, offering the potential of partial disease reversal. Data from a phase 2 study and three phase 3 studies demonstrate robust efficacy. However, unique safety signals have also emerged, both in the clinical trial program as well as in post-marketing surveillance. This article summarizes the present evidence and outlines steps to optimize the benefit-risk ratio of sotatercept and future ASIs.