European Commission approves yuvanci for pulmonary arterial hypertension treatment

Janssen-Cilag therapy becomes the first single tablet combination therapy for PAH in europe

The European Commission has approved Yuvanci (macitentan 10 mg and tadalafil 40 mg), a single tablet combination therapy (STCT) for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients. This approval marks a significant milestone as Yuvanci becomes the only single tablet option available for PAH patients in Europe.

Janssen-Cilag International NV, a Johnson & Johnson company, announcement has highlighted the comprehensive PAH portfolio that now covers all three guideline-recommended foundational treatment pathways.

“In the Phase 3 A DUE study, the macitentan and tadalafil single tablet combination therapy demonstrated a reduction of 29 percent in pulmonary vascular resistance as compared to macitentan, and 28 percent reduction as compared to tadalafil,” said Professor Ekkehard Grunig, MD, Professor of Internal Medicine at Heidelberg University.

He added: “These results, along with the consistent efficacy across different patient subgroups, are encouraging. This single tablet combination therapy represents an important new treatment option for many people living with PAH, who, until now, had no single tablet option available.”

PAH is a rare, progressive, and life-threatening disease characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation, eventually leading to right heart failure and death.

Initial double combination therapy with macitentan and tadalafil for PAH patients without cardiopulmonary comorbidities has the highest class of recommendation in the 2022 European Society of Cardiology/European Respiratory Society (ESC/ERS) pulmonary hypertension guidelines.

“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,” said Tamara Werner-Kiechle, EMEA Therapeutic Area Lead Neuroscience and Cardiopulmonary, Johnson & Johnson Innovative Medicine. “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 ESC/ERS guidelines.”

The EC approval is based on results from the Phase 3 A DUE study, a multi-national, multi-centre, double-blind, adaptive, randomised, active-controlled, parallel-group study in 187 adult patients with PAH (WHO FC II to III).

The study met its primary endpoint, demonstrating a significant change in pulmonary vascular resistance for the comparison of M/T STCT versus the individual monotherapies.