EC Approves Johnson & Johnson's Yuvanci for Pulmonary Arterial Hypertension

Johnson & Johnson’s (J&J) newly approved Yuvanci, a single tablet combination therapy (STCT) of macitentan and tadalafil, is set to offer a new treatment option for pulmonary arterial hypertension (PAH) in Europe. The European Commission (EC) approved Yuvanci as a long-term substitution therapy for adults classified under World Health Organization functional class two to three, who are currently undergoing treatment with macitentan and tadalafil as separate medications.

PAH is a serious disease that affects up to 55 per million adults. It causes the blood vessels in the lungs to thicken and narrow, obstructing blood flow and increasing blood pressure, which puts significant stress on the heart. Macitentan, one of the components of Yuvanci, helps by dilating these narrowed blood vessels, facilitating easier blood flow from the heart to the lungs, and preventing cellular overgrowth in the vessel walls. Tadalafil, the other component, relaxes and widens blood vessels in the lungs, thereby reducing pulmonary blood pressure and enhancing heart function.

Up until now, European PAH patients did not have access to a single pill that addresses multiple PAH-specific pathways. The EC’s decision to approve Yuvanci was influenced by a recommendation from the European Medicines Agency’s human medicines committee. This recommendation was supported by positive findings from the A DUE study, which demonstrated that Yuvanci achieved reductions in pulmonary vascular resistance by 29% and 28%, compared to macitentan and tadalafil monotherapies, respectively.

Tamara Werner-Kiechle, the EMEA therapeutic area lead for neuroscience and cardiopulmonary at J&J Innovative Medicine, emphasized the importance of this approval. She noted that individuals living with PAH often face complex treatment regimens that require multiple medications daily, which can complicate their lives and adherence to prescribed treatments. According to Werner-Kiechle, this new approval addresses a significant unmet need within the PAH community. She added that J&J is pleased to introduce an innovative treatment option that aligns with the European Society of Cardiology/European Respiratory Society guidelines, which advocate for initial double combination therapy with timely escalation to triple therapy.

In summary, Johnson & Johnson’s Yuvanci has been approved by the European Commission as a single tablet combination therapy for the long-term treatment of PAH. This new approval promises to simplify treatment regimens for PAH patients, potentially improving adherence and overall quality of life.