FDA approves J&J’s Opsynvi for PAH treatment

Betsy Goodfellow | March 25, 2024 | News story | Medical Communications Cardiology, FDA, J&J, Johnson & Johnson, Opsynvi, pulmonary arterial hypertension 

Johnson & Johnson (J&J) has announced that the US Food and Drug Administration (FDA) has approved Opsynvi (macitentan and tadalafil) for the chronic treatment of adults with pulmonary arterial hypertension (PAH). 

The drug is approved for use in patients who are ‘currently treated concomitantly with stable doses of macitentan 10mg and tadalafil 40mg as separate tablets’, according to the press release.

This approval follows results from the pivotal phase 3 A DUE study, in which the drug demonstrated a greater reduction in Pulmonary Vascular Resistance (PVR) after 16 weeks of treatment compared to tadalafil or macitentan as monotherapies.

The drug has a Boxed Warning due to risk of embryo-foetal toxicity and requires any female patients to enroll in the Maceitentan-Containing Products Risk Evaluation and Mitigation Strategy (REMS) programme.

James F List MD PhD, global therapeutic area head at J&J, commented: “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 fulfill a significant unmet need in supporting recently updated treatment guidelines that call for initial or early combination treatment.”

Betsy Goodfellow

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