NEW BRUNSWICK (dpa-AFX) - 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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