Johnson & Johnson has announced that its Opsynvi (macitentan and tadalafil) has been approved by the US Food and Drug Administration (FDA) to treat adult patients with pulmonary arterial hypertension (PAH) who are treatment-naïve or who are already on an endothelin receptor antagonist (ERA), phosphodiesterase 5 (PDE5) inhibitor or both.
The approval marks Opsynvi as the first and only once-daily single-tablet combination therapy for this patient population.
Responsible for up to 1,000 new diagnoses every year in the US, PAH is a rare, progressive and life-threatening form of pulmonary hypertension, which occurs when there is high blood pressure in the lungs.
For people living with PAH, obstruction in the small arteries in the lung increases pressure in the vessels, which can eventually lead to blood vessels.
The FDA’s decision was based on results from the pivotal phase 3 A DUE study which evaluated the efficacy and safety of Opsynvi versus macitentan and tadalafil monotherapies in a total of 187 adult PAH patients from across 148 sites in 19 countries worldwide.
Opsynvi, a combination of macitentan, an ERA, and tadalafil, a PDE5 inhibitor, is indicated for the chronic treatment of PAH in adult patients of World Health Organization functional classes two to three.
Results showed that Opsynvi demonstrated a greater reduction in pulmonary vascular resistance (VPR) after 16 weeks versus tadalafil or macintentan monotherapy and the safety profile of the therapy was consistent with the known safety profiles of the monotherapies, with no new safety observations.
The decision now means Johnson & Johnson offers a PAH portfolio that addresses all three foundational and guideline-recommended pathways: nitric oxide, endothelin and prostacyclin.
Kelly Chin, professor of internal medicine and director, Pulmonary Hypertension Program at UT Southwestern Medical Center, said that Opsynvi “is promising for clinicians treating patients as it may help bridge the gap between clinical guidelines and everyday clinical practice”.