Macitentan/tadalafil

Macitentan/tadalafil, sold under the brand name Opsynvi, is a fixed dose combination medication used for the treatment of pulmonary arterial hypertension. It contains macitentan, an endothelin receptor antagonist ; and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor.
Macitentan/tadalafil was approved for medical use in Canada in October 2021, in the United States in March 2024, and in the European Union in September 2024.

Medical uses

Macitentan/tadalafil is indicated for the chronic treatment of pulmonary arterial hypertension in adults of WHO functional class II-III.

Adverse effects

Macitentan/tadalafil may cause harm to the fetus.

Society and culture

Legal status

In July 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Yuvanci, intended for the treatment of pulmonary arterial hypertension. The applicant for this medicinal product is Janssen-Cilag International NV. The combination was authorized for medical use in the European Union in September 2024.