On March 22, 2024 the Food and Drug Administration (FDA), the US drug regulatory authority, approved the single-tablet macitentan/tadalafil combination (Opsynvi) for pulmonary arterial hypertension. The application to the FDA was submitted by the Janssen Pharmaceutical Companies of Johnson & Johnson on May 30, 2023. The FDA approval is based on the results of the Phase 3 A DUE study, where the single tablet demonstrated significant improvements in pulmonary hemodynamics, surpassing the effects of macitentan and tadalafil monotherapies within the pulmonary arterial hypertension patient population.. Macintentan belongs to the class of drugs known as endothelin receptor antagonists and tadalafil to that of the PDE-5 inhibitors.
Read the annoucement at this link on the Johnson & Johson website.
An application for new drug approval for the single tablet macintentan/tadalafil has also been submitted to the European drug regulatory authority, the European Medicine’s Agency (EMA) (June 26, 2023). To be followed.
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