Johnson & Johnson's Opsynvi Receives FDA Approval as First Single-Tablet Combination Therapy for Pulmonary Arterial Hypertension

On March 23, Johnson & Johnson (JNJ.US) announced that the U.S. FDA approved its Opsynvi single-tablet combination therapy for the long-term treatment of adult patients with pulmonary arterial hypertension (PAH) classified as WHO Functional Class (FC) II-III. The approval of Opsynvi enables Johnson & Johnson’s PAH portfolio to cover all guideline-recommended PAH-targeted pathways.It is reported that Opsynvi is the first single-tablet combination therapy for PAH to receive FDA approval.

The FDA approval of Opsynvi was mainly based on the pivotal A DUE Phase 3 clinical study results.Among them, Opsynvi demonstrated a greater reduction in pulmonary vascular resistance (PVR) after 16 weeks of treatment compared to tadalafil or macitentan monotherapy.

Notably, the safety of Opsynvi is consistent with the known safety profiles of macitentan and tadalafil monotherapies, with no new safety concerns identified.

Editor: Ouyang Mingjun