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Johnson & Johnson announced today that the U.S. FDA has approved its Opsynvi single-tablet combination therapy for the long-term treatment of adult patients with pulmonary arterial hypertension (PAH) classified as WHO Functional Class (FC) II-III. The approval of Opsynvi enables Johnson & Johnson’s PAH portfolio to cover all guideline-recommended PAH-targeted pathways.According to the press release, Opsynvi is the first single-tablet combination therapy for PAH to receive FDA approval.

The FDA approval of Opsynvi in the United States was primarily based on the pivotal A DUE Phase 3 clinical study results.Among them, Opsynvi has been proven to be related to tadalafil orMacitentanCompared with monotherapy, patients had a greater reduction in pulmonary vascular resistance (PVR) after 16 weeks of treatment.AndMacitentanIn comparison, the PVR change with Opsynvi was significantly greater (treatment effect: 29%; 95% CI: -18%, -39%, p<0.0001). Compared with tadalafil, the PVR change with Opsynvi was also significantly greater (treatment effect: 28%; 95% CI: -20%, -36%, p<0.0001).

The safety of Opsynvi is consistent with the known safety profiles of macitentan and tadalafil monotherapies, with no new safety concerns identified.

Opsynvi (M/T STCT) is an endothelin receptor antagonist (ERA) macitentan (10 mg) and phosphodiesterase-5 (PDE5) inhibitor tadalafil (40 mg) in a single-tablet combination, taken once daily.Macitentan and Tadalafil are both used for the treatment of PAH. Macitentan can reduce the risk of clinical worsening events and hospitalization, while Tadalafil can improve patients' exercise capacity.

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References:

[1] U.S. FDA Approves OPSYNVI® (macitentan and tadalafil) as the First and Only Once-Daily Single-Tablet Combination Therapy for Patients with Pulmonary Arterial Hypertension (PAH). Retrieved March 22, 2024 from https://www.prnewswire.com/news-releases/us-fda-approves-opsynvi-macitentan-and-tadalafil-as-the-first-and-only-once-daily-single-tablet-combination-therapy-for-patients-with-pulmonary-arterial-hypertension-pah-302097530.html

[2] Late-Breaking Phase 3 A DUE Data Show Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil Significantly Improves Pulmonary Hemodynamics versus Monotherapy in Patients with Pulmonary Arterial Hypertension (PAH). Retrieved March 22, 2024 from https://www.jnj.com/media-center/press-releases/late-breaking-phase-3-a-due-data-show-investigational-single-tablet-combination-therapy-of-macitentan-and-tadalafil-significantly-improves-pulmonary-hemodynamics-versus-monotherapy-in-patients-with-pulmonary-arterial-hypertension-pah

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