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 (ERA); 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 (PAH, WHO Group I) in adults of WHO functional class (FC) 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 (PAH). 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.
References
External links Clinical trial number NCT03904693 for "Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) (A DUE)" at ClinicalTrials.gov
