Johnson & Johnson Receives FDA Approval for Opsynvi, the First Single-Tablet Combination Therapy for Pulmonary Arterial Hypertension

Mar 24, 2024 08:31 CST Updated 08:31

Johnson & Johnson

Healthcare Product Manufacturers, Health Service Providers

On March 22, Johnson & Johnson announced that the U.S. FDA approved the listing of Opsynvi single-tablet combination therapy for the long-term treatment of adult patients with pulmonary arterial hypertension (PAH) classified as World Health Organization (WHO) functional class (FC) II-III. Opsynvi is a single-tablet formulation composed of the endothelin receptor antagonist (ERA) macitentan and the phosphodiesterase-5 (PDE5) inhibitor tadalafil.OpsynviCan be used for PAH patients who have not previously used or have already received ERA, PDE5 inhibitors, or both.

PAH is a rare, progressive, and life-threatening vascular disease characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation, ultimately leading to right heart failure.Currently, several drugs have been approved for the treatment of PAH, including prostacyclin I2 (PGI2) analogs, PGI2 receptor agonists, endothelin receptor antagonists (ERA), PDE5 inhibitors, and nitric oxide (NO), but all these drugs are single-agent formulations.

The 2022 European Society of Cardiology (ESC) / European Respiratory Society (ERS) clinical guidelines recommend initial combination therapy with ERA and PDE5 inhibitors for patients with idiopathic PAH, heritable drug-associated PAH, or connective tissue disease-associated PAH without cardiopulmonary comorbidities.

This approval is based on the positive results of the pivotal Phase III A DUE study,This study is a multicenter, randomized, double-blind, positive drug-controlled Phase III clinical trial, enrolling a total of 187 adult PAH patients who were either treatment-naïve or had received fixed-dose ERA/PDE5i therapy for at least 3 months. The aim is to evaluate the efficacy and safety of the macitentan-tadalafil combination compared to macitentan monotherapy (10mg) or tadalafil monotherapy (40mg).The primary endpoint of the study was the change in PVR at Week 16 compared to baseline (the ratio of the geometric mean to the baseline value).

The results showed that the reduction in PVR in the combination group was significantly greater than that in the macitentan group (change: 29%; 95% CI: -18%, -39%; P<0.0001) and also significantly greater than that in the tadalafil group (change: 28%; 95% CI: -20%, -36%; P<0.0001). However, the study did not achieve the secondary endpoint of a significant increase in the 6-minute walking distance (6MWD) at week 16. Nevertheless, the increase in 6MWD was clinically meaningful.In addition, the safety of this compound is consistent with the safety of macitentan and tadalafil monotherapy in previous studies, and no new issues have been found.No new safety signals were observed.

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