The FDA approval of Opsynvi, a combination of two proven treatments with established efficacy and safety profiles into a single once-daily tablet, is based on the results from the Phase 3 A DUE study that met its co-primary endpoints
J&J secures FDA approval for Opsynvi. (Credit: Thought Catalog on Unsplash)
Johnson & Johnson (J&J) has received the US Food and Drug Administration (FDA) approval for Opsynvi to treat a type of pulmonary arterial hypertension (PAH) in adult patients.
Opsynvi is a single-tablet combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor.
Individually, macitentan reduces the risk of clinical worsening events and hospitalization, and tadalafil improves exercise ability.
The drug is indicated for chronic treatment of adults with pulmonary arterial hypertension (PAH), World Health Organization (WHO) Group I and WHO functional class (FC) II-III.
Opsynvi comes with a boxed warning about the risk of embryo-foetal toxicity and requires female patients to enrol in the Risk Evaluation and Mitigation Strategy (REMS) programme.
Johnson & Johnson global therapeutic area head James List said: “People with PAH often live with the burden of taking many pills each day, which can pose challenges.
“We’re thrilled to bring this single tablet combination therapy to patients, as it has the potential to optimize disease management and fulfil a significant unmet need in supporting recently updated treatment guidelines that call for initial or early combination treatment.”
The FDA approval of Opsynvi is based on the results from the pivotal Phase 3 A DUE study, a double-blind, randomised, active-controlled, multi-center, adaptive, parallel-group study.
The trial enrolled patients from across 76 sites in 16 countries worldwide, who were treatment-naïve or on a stable dose of an ERA, or a PDE5 inhibitor, for at least three months.
In the Phase 3 study, treatment using Opsynvi showed a greater reduction in Pulmonary Vascular Resistance (PVR) compared to tadalafil or macitentan monotherapy.
With the approval, J&J now offers a PAH portfolio addressing all three foundational and guideline-recommended pathways, nitric oxide, endothelin, and prostacyclin.
A DUE study investigator Kelly Chin said: “Clinical guidelines recommend treating patients with initial and sequential dual-combination therapy, regardless of risk at initial diagnosis and follow-up.
“Historically, this required patients to take multiple pills because no single-tablet combination therapy targeting two or more pathways was available.
“The introduction of a single tablet combining both is promising for clinicians treating patients as it may help bridge the gap between clinical guidelines and everyday clinical practice.”