Johnson & Johnson’s (J&J) Yuvanci (macitentan and tadalafil) has been recommended by the European Medicines Agency’s human medicines committee as a single tablet combination therapy (STCT) for adults with pulmonary arterial hypertension (PAH).
The combination therapy has specifically been recommended by the Committee for Medicinal Products for Human Use (CHMP) as a substitution therapy for the long-term treatment of PAH in adult patients of World Health Organization (WHO) functional class (FC) two or three who are already receiving a combination of Actelion Pharmaceuticals endothelin receptor antagonist (ERA), Opsumit (macitentan) and Eli Lilly’s phosphodiesterase 5 inhibitor (PDE5i), Cialis (tadalafil) as separate tablets.
Affecting around 30,000 people in the EU, PAH is a rare, progressive and life-threatening form of pulmonary hypertension in which the blood vessels in the lungs thicken and narrow and elevate blood pressure, which can lead to heart failure and death.
The CHMP’s recommendation was based on positive results from the phase 3 A DUE study, which compared the efficacy and safety of Yuvanci STCT of macitentan 10mg and tadalafil 40mg (M/T STCT) to each monotherapy in 187 adult patients with WHO FC two or three PAH.
The study met its primary endpoint after Yuvanci demonstrated a 29% and 28% reduction, respectively, in pulmonary vascular resistance (PVR) at week 16 to baseline in patients with PAH versus the individual monotherapies.
In addition, M/T STCT demonstrated consistent efficacy in patients who were either treatment-naïve or previously exposed to an ERA or PDE5i.
James List, global therapeutic area head, cardiopulmonary, J&J Innovative Medicine, commented: “[This] positive opinion represents a significant step forward and underlines our commitment to providing solutions for patients in the PAH community [and]… we look forward to working with health authorities to bring our [STCT] to adult patients in need across the region as soon as possible.”
If approved by the European Commission, Yuvanci will be the first and only STCT in the EU to treat patients living with PAH and expand J&J’s PAH portfolio to cover all guideline-recommended treatment pathways.
The recommendation comes after the US Food and Drug Administration approved Opsynvi (macitentan and tadalafil) in March 2024 for the treatment of patients with PAH.