Drug Efficacy IssuesSubgroup analyses suggest limited effect of Winrevair in patients with connective tissue disease, a significant portion of the PAH patient population.
Drug Safety ConcernsThe label includes warnings for Winrevair related to erythrocytosis, hemoglobin increases, and severe thrombocytopenia, requiring monitoring.
Regulatory ChallengesSotatercept's dose-dependent effects on hemoglobin and vascular adverse events could necessitate a REMS, highlighting potential safety risks.