J&J's single-pill option for pulmonary arterial hypertension wins FDA nod

2024-03-24

临床3期上市批准临床结果并购

Johnson & Johnson has secured FDA approval for Opsynvi (macitentan/tadalafil), making it the first single-tablet combination therapy for adults with pulmonary arterial hypertension (PAH).

The drug is a fixed-dose combo of the endothelin receptor antagonist Opsumit (macitentan), which landed in Johnson & Johnson's portfolio after its $30-billion Actelion buyout in 2017, and the PDE5 inhibitor tadalafil, which is marketed for PAH by United Therapeutics under the named Adcirca.

"As administration of macitentan and tadalafil together are commonly prescribed for initial therapy for PAH, the introduction of a single tablet combining both…may help bridge the gap between clinical guidelines and everyday clinical practice, while offering a patient-friendly approach to support initial combination therapy and rapid escalation," said Kelly Chin, an investigator on the Phase III A DUE study on which the filing was based.

Improved blood flow in pulmonary vessels

The trial enrolled 187 PAH patients who were either treatment-naïve or already on a stable dose of an endothelin receptor antagonist or a PDE5 inhibitor.

Results presented at last year's American College of Cardiology (ACC) conference demonstrated that Opsynvi significantly improved blood flow through pulmonary blood vessels, compared to macitentan and tadalafil monotherapies, in PAH patients with World Health Organization functional class II or III.

Patients treated with Opsynvi had a 29% greater reduction in pulmonary vascular resistance (PVR) compared to those taking macitentan alone, and a 28% greater reduction in PVR compared to those on tadalafil alone. Further, while the A DUE study wasn't specifically designed to show a benefit in exercise capacity, Johnson & Johnson noted at the time that it did reveal a "clinically relevant improvement" in a six-minute walk test.

Opsynvi comes with a boxed warning about the risk of embryo-foetal toxicity, and requires female patients to join the Risk Evaluation and Mitigation Strategy (REMS) programme for macitentan-containing products. The single-tablet combination therapy is also under review in Europe.

Johnson & Johnson has been pursuing strategies to expand the use of Opsumit ahead of its US patent expiry in 2025. In September, the company scrapped the Phase III MACiTEPH trial of Opsumit in patients with chronic thromboembolic pulmonary hypertension (CTEPH) due to futility. The drug, which has been approved in the US since 2013 as a treatment for PAH, generated sales totaling $2 billion last year.

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