CHMP Recommends Johnson & Johnson's Yuvanci for Pulmonary Arterial Hypertension

Johnson & Johnson's (J&J) Yuvanci, a single tablet combination therapy (STCT) of macitentan and tadalafil, has been recommended by the European Medicines Agency’s human medicines committee for use in adults with pulmonary arterial hypertension (PAH). This recommendation by the Committee for Medicinal Products for Human Use (CHMP) is specifically aimed at adult patients classified under the World Health Organization (WHO) functional class (FC) two or three, who are already undergoing treatment with separate tablets of Actelion Pharmaceuticals' endothelin receptor antagonist (ERA), Opsumit (macitentan), and Eli Lilly’s phosphodiesterase 5 inhibitor (PDE5i), Cialis (tadalafil).

PAH is a rare and progressive disease affecting around 30,000 people in the European Union. The condition leads to the thickening and narrowing of the blood vessels in the lungs, causing elevated blood pressure, which can result in heart failure and death. 

The CHMP's recommendation for Yuvanci is based on positive outcomes from the phase 3 A DUE study. This study assessed the efficacy and safety of Yuvanci, combining macitentan 10mg and tadalafil 40mg (M/T STCT), against each monotherapy in 187 adult patients with WHO FC two or three PAH. The study achieved its primary endpoint, showing that Yuvanci led to a 29% and 28% reduction in pulmonary vascular resistance (PVR) at week 16 compared to baseline, surpassing the reduction achieved by the individual monotherapies.

Moreover, the M/T STCT demonstrated consistent efficacy not only in treatment-naïve patients but also in those who had previously been treated with an ERA or PDE5i. James List, global therapeutic area head for cardiopulmonary at J&J Innovative Medicine, highlighted that the positive opinion marks a significant advancement and emphasizes J&J’s commitment to offering solutions for the PAH community. He added that they are eager to collaborate with health authorities to make the STCT available to adult patients in need across the region as swiftly as possible.

Should the European Commission approve Yuvanci, it will become the first and only STCT available in the EU for managing PAH. This approval would also expand J&J’s portfolio to include all guideline-recommended treatment pathways for PAH. 

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