Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has approved OPSYNVI for the chronic treatment of adults with pulmonary arterial hypertension (PAH). The newly-approved drug is a single-tablet combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor.
The combination tablet (Opsynvi; Johnson & Johnson) can also be used for individuals with pulmonary arterial hypertension who are being treated with stable doses of macitentan and tadalafil as separate tables.
The approval, which marks the first for a once-daily, single-tablet combination therapy for pulmonary arterial hypertension, is based on findings from the phase 3 A DUE study.