CHMP recommends Yuvanci (macitentan + tadalafil) to treat pulmonary arterial hypertension – Johnson & Johnson

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation 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.

Yuvanci (Opsynvi in the US), is a fixed dose combination of two active substances and will be available as film-coated tablets containing 10 mg macitentan and either 20 or 40 mg tadalafil. The active substances of Yuvanci are macitentan and tadalafil, anti-hypertensives for PAH (ATC code: C02KX54). Macitentan is an orally active endothelin receptor antagonist which binds to endothelin receptors on pulmonary arterial smooth muscle cells, thereby reducing vasoconstriction and smooth muscle cell proliferation. Tadalafil is a selective inhibitor of PDE5 which relaxes pulmonary vascular smooth muscle cells and induces the vasodilation of the pulmonary vascular bed.

The benefit of Yuvanci is the reduction in pulmonary vascular resistance at week 16 of treatment in patients with PAH compared with macitentan or tadalafil monotherapy, as observed in a randomised study. Yuvanci was generally well tolerated and had a manageable safety profile, in line with that of the monotherapies. The most common side effects with Yuvanci are anaemia/haemoglobin decrease, oedema/fluid retention and headache.