Research & Development
Johnson & Johnson's OPSYNVI receives US FDA approval
25 March 2024 -

Johnson & Johnson, a United States-based multinational, pharmaceutical, and medical technologies corporation, announced on Friday that it has received approval from the US Food and Drug Administration (FDA) for its OPSYNVI, a single-tablet combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor, intended for the chronic treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group I) and WHO functional class (FC) II-III.

OPSYNVI may be used in patients with PAH who are treatment-naïve or who are already on an ERA, PDE5 inhibitor or both. OPSYNVI may be used in patients who are currently treated concomitantly with stable doses of macitentan 10mg and tadalafil 40mg (20mg x 2) as separate tablets.

The FDA's approval of OPSYNVI is based on the results from the pivotal Phase 3 A DUE study, in which OPSYNVI demonstrated greater reduction in Pulmonary Vascular Resistance (PVR) after 16 weeks versus tadalafil or macitentan monotherapy. OPSYNVI has a Boxed Warning due to the risk of embryo-foetal toxicity and requires female patients to enrol in the Macitentan-Containing Products Risk Evaluation and Mitigation Strategy (REMS) program.