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# J&J’s Opsynvi OK’d for Pulmonary Hypertension
- URL: https://www.fdaweb.com/j-js-opsynvi-okd-for-pulmonary-hypertension/
- Published: 2024-03-25T12:00:00.000Z
- Updated: 2026-09-14T14:26:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156621

FDA has approved Johnson & Johnson’s Opsynvi, a combination single tablet of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor, for treating adults with pulmonary arterial hypertension (PAH, World Health Organization \[WHO\] Group I) and WHO functional class (FC) II-III. The company says Opsynvi may be used in patients with PAH who are treatment-naïve or who are already on an ERA, PDE5 inhibitor or both.

PAH is described as a rare, progressive and life-threatening blood vessel disorder where small pulmonary arteries are constricted that leads to elevated blood pressure in the pulmonary circulation that eventually leads to right heart failure. Less than 1,000 new PAH cases are diagnosed each year in the U.S.

Approval was based on data from the pivotal Phase 3 A DUE study, in which Opsynvi showed a greater reduction in pulmonary vascular resistance after 16 weeks versus tadalafil or macitentan monotherapy.

On the safety side, Opsynvi has a Boxed Warning due to the risk of embryo-fetal toxicity and the labeling requires female patients to enroll in the Macitentan-Containing Products Risk Evaluation and Mitigation Strategy (REMS) program because of this.