The US Food and Drug Administration (FDA) has granted approval for Johnson & Johnson‘s (J&J) OPSYNVI for chronic treatment of adult patients with pulmonary arterial hypertension (PAH), World Health Organization Group I and WHO functional classes II and III.

OPSYNVI is a single-tablet formulation comprising the endothelin receptor antagonist (ERA) macitentan and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor.

It is indicated for patients who are treatment-naïve or receiving ERA or PDE5 inhibitors or both.

These patients have been treated concurrently with stable doses of macitentan 10mg and tadalafil 40mg as separate pills.

The approval is based on Phase III A DUE study results, which showed OPSYNVI reduced pulmonary vascular resistance (PVR) compared to tadalafil or macitentan monotherapies after 16 weeks.

The three-arm, randomised, double-blind, active-controlled, multicentre, parallel-group, adaptive trial aimed to compare the efficacy and safety of OPSYNVI with macitentan and tadalafil single agents.

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It enrolled participants at 76 sites in 16 countries and territories.

The trial’s primary endpoint was the change from the PVR baseline at the end of the 16-week double-blind treatment period.

OPSYNVI’s approval marks a significant addition to J&J’s PAH portfolio, which now addresses all three foundational and guideline-recommended pathways: nitric oxide, endothelin and prostacyclin.

However, OPSYNVI comes with a boxed warning due to embryo-foetal toxicity risk. Female patients should therefore enrol in the Macitentan-Containing Products Risk Evaluation and Mitigation Strategy programme.

J&J 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 optimise disease management and fulfil a significant unmet need in supporting recently updated treatment guidelines that call for initial or early combination treatment.”

The latest development comes after the company received FDA approval for EDURANT PED to treat human immunodeficiency virus-1 in children.