Posted by Michael Wonder on 25 Mar 2024
US FDA approves Opsynvi (macitentan and tadalafil) as the first and only once daily single tablet combination therapy for patients with pulmonary arterial hypertension
22 March 2024 - Approval is based on the results from the pivotal Phase 3 A DUE study, which met its co-primary endpoints, demonstrating significant pulmonary haemodynamic improvement.
Johnson & Johnson today announced that the US FDA has approved Opsynvi – a single-tablet combination of macitentan, an endothelin receptor antagonist, and tadalafil, a phosphodiesterase 5 inhibitor – for the chronic treatment of adults with pulmonary arterial hypertension (World Health Organization Group I and functional class II-III.
