Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved OPSYNVI®? - a single-tablet combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor - for the chronic treatment of adults with pulmonary arterial hypertension and WHO functional class (FC) II-III. OPSYNVI®?

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

PAH is a rare, progressive and life-threatening blood vessel disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation that eventually leads to right heart failure. An estimated 500 to 1,000 new cases of PAH are diagnosed each year in the U.S., classifying the disease as a rare condition. The 2022 European Society of Cardiology (ESC) /European Respiratory Society (ERS) clinical guidelines recommend initial combination therapy of an ERA and a PDE5 inhibitor for patients with idiopathic PAH, heritable drug-associated PAH, or PAH-associated with connective tissue disease without cardiopulmonary comorbidities at low or intermediate risk.

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 mac penan monotherapy.OPSYNVI®?

has a Boxed Warning due to the risk of embryo-fetal toxicity and requires female patients to enroll in the Macitentan-Containing Products Risk Evaluation and Mitigation Strategy (REMS) program. With the approval, Johnson & Johnson now offers a PAH portfolio addressing all three foundational and guideline-recommended pathways - nitric oxide, endothelin, and prostacyclin. For all female patients, OPSYNVI®?

is available only through a restricted program called the Macitentan-Contained Products Risk Evaluation and Mitigation strategy (REMS). R risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to competitors; challenges to improve the risk of pulmonary arterial hypertension; and safety profile and safety profile.