Macitentan/tadalafil was approved for medical use in Canada in October 2021,[3] and in the United States in March 2024.[4][5]
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.[2]
Adverse effects
Macitentan/tadalafil may cause harm to the fetus.[2]
Society and culture
Legal status
In July 2024, the Committee for Medicinal Products for Human Use (CHMP) 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).[6] The applicant for this medicinal product is Janssen-Cilag International NV.[6]
^ ab"Yuvanci EPAR". European Medicines Agency. 25 July 2024. Retrieved 27 July 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
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