Johnson & Johnson's Yuvanci Gets Positive CHMP Opinion In Europe For Pulmonary Arterial Hypertension

(RTTNews) - Janssen-Cilag International NV, affiliated to drug major Johnson & Johnson (JNJ), announced Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP has recommended the Marketing Authorisation of Yuvanci, a combination therapy of Macitentan and Tadalafil, for treating Pulmonary Arterial Hypertension or PAH.

PAH is a rare, progressive and life-threatening disease characterised by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation that eventually leads to right heart failure and death.

Johnson & Johnson's Yuvanci is a single tablet combination therapy of macitentan 10 mg and tadalafil 40 mg (M/T STCT) as a substitution therapy for the long-term treatment of PAH in adult patients of WHO Functional Class or FC II to III, who are already treated with the combination of macitentan and tadalafil given concurrently as separate tablets.

If approved by the European Commission, Yuvanci would become the only single tablet combination for treatment for patients with PAH in Europe.

The CHMP positive opinion for M/T STCT is based on data from the Phase 3 A DUE study, which met its primary endpoint, demonstrating change in pulmonary vascular resistance.

The positive CHMP opinion follows the New Drug Application approval of OPSYNVI (macitentan and tadalafil) by the U.S. Food and Drug Administration in March 2024 for the treatment of patients with PAH.

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