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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, and in the United States in March 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 (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). The applicant for this medicinal product is Janssen-Cilag International NV.

References

1. "Health product highlights 2021: Annexes of products approved in 2021". Health Canada. 3 August 2022. Archived from the original on 25 March 2024. Retrieved 25 March 2024.
2. ^ "Opsynvi- macitentan and tadalafil tablet, film coated". DailyMed. 22 March 2024. Archived from the original on 2 April 2024. Retrieved 2 April 2024.
3. "Opsynvi (macitentan and tadalafil) Becomes the First and Only Health Canada-Approved Once Daily Fixed Dose Combination Treatment for Patients with Pulmonary Arterial Hypertension (PAH)". Johnson & Johnson (Press release). 15 October 2021. Archived from the original on 25 March 2024. Retrieved 25 March 2024.
4. "Approval Letter: Opsynvi (macitentan and tadalafil)" (PDF). U.S. Food and Drug Administration. Archived (PDF) from the original on 25 March 2024. Retrieved 25 March 2024.
5. "U.S. FDA Approves Opsynvi (macitentan and tadalafil) as the First and Only Once-Daily Single-Tablet Combination Therapy for Patients with Pulmonary Arterial Hypertension (PAH)". Johnson & Johnson (Press release). 22 March 2024. Archived from the original on 25 March 2024. Retrieved 25 March 2024.
6. ^ "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

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