Johnson & Johnson’s (J&J) Yuvanci (single tablet combination therapy [STCT] of macitentan and tadalafi) has been approved by the European Commission (EC) as a long-term treatment for pulmonary arterial hypertension (PAH).
The STCT has been specifically authorised for use as a substitution therapy in adults of World Health Organization functional class two to three, who are already treated with the combination of macitentan and tadalafil as separate tablets.
Affecting up to 55 per million adults, PAH is a progressive and life-threatening disease in which the blood vessels in the lungs thicken and narrow. This blocks the blood flow through the lungs, which raises blood pressure and results in a significant strain on the heart.
Macitentan works by dilating the narrow blood vessels between the right side of the heart and the lungs, making it easier for the heart to pump blood through them, as well as reducing and preventing the overgrowth of cells in the walls of these vessels; while tadalafil is designed to relax the blood vessels in the lungs, widening them to decrease the pulmonary blood pressure to the heart and improve its function.
Until now, no single tablet that targets two or more PAH-specific pathways has been available for PAH patients in Europe.
The EC’s decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and was based on positive results from the late-stage A DUE study, in which Yuvanci demonstrated 29% and 28% reductions in pulmonary vascular resistance compared to macitentan and tadalafil monotherapies, respectively.
Tamara Werner-Kiechle, EMEA therapeutic area lead neuroscience and cardiopulmonary, J&J Innovative Medicine, said: “People living with PAH face complex treatment regimens, with many having to take multiple pills per day. This can deeply impact their daily lives as they might struggle to maintain adherence to their treatment regimen.
“This approval addresses a significant unmet need for the PAH community and we are delighted to bring a new and innovative treatment option to adults living with PAH that follows the European Society of Cardiology/European Respiratory Society guidelines, which recommend initial double and timely escalation to triple combination therapy.”