Approvals

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 approva l 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 embr yo-foetal toxicity and requires any female patients to enrol in the Macitentan-Containing Products Risk Evaluation and Mitigation Strateg y (R EMS) 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 fulfil a significant unmet need in supporting recently updated treatment guidelines that call for initial or early combination treatment.”

Kelly Chin MD, professor of Internal Medicine and Director of the Pulmonary Hy pertension Programme at UT Southwestern Medical Center, and an investigator in the A DUE study, added: “Clinical guidelines recommend treating patients with initial and sequential dua l-combination therapy, regardless of risk at initial diagnosis and fol low-up. Historically, this required patients to take multiple pills because no single-tablet combination therapy targeting two or more pathways was available. As administration of macitentan and tadalafil together are commonly prescribed for initial therapy for PAH, 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 ever yday clinical practice, while offering a patient-friendly approach to support initial combination therapy and rapid escalation for the appropriate patients.”