U.S. FDA approves OPSYNVI®, a single-tablet PAH therapy combining macitentan and tadalafil.

The U.S. FDA approved OPSYNVI®, a single-tablet combination of macitentan and tadalafil, as the first once-daily therapy for pulmonary arterial hypertension (PAH). The drug combines proven treatments with established efficacy and safety profiles, supporting early use of combination therapy. The approval is based on the pivotal Phase 3 A DUE study, which demonstrated significant pulmonary hemodynamic improvement.