Janssen-Cilag therapy becomes the first single-tablet combination therapy for PAH in Europe
Yuvanci, a single-tablet combination therapy (STCT) consisting of macitentan 10 mg and tadalafil 40 mg, has been authorized by the European Commission for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients. Since Yuvanci is now the sole single-tablet alternative available to PAH patients in Europe, this approval represents a significant milestone.
The announcement from Johnson & Johnson subsidiary Janssen-Cilag International NV highlighted the entire PAH portfolio, which now includes all three core treatment paths indicated by guidelines.
“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.
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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.”
Small pulmonary artery constriction and increased blood pressure in the pulmonary circulation are hallmarks of PAH, an uncommon, life-threatening condition that ultimately results in right heart failure and death.
Initial twofold combination therapy with macitentan and tadalafil for PAH patients without cardiac comorbidities has the highest class of recommendation in the 2022 European Society of Cardiology/European Respiratory Society (ESC/ERS) pulmonary hypertension recommendations.
“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 Phase 3 A DUE trial, a multi-national, multi-center, adaptive, randomized, active-controlled, parallel-group investigation with 187 adult PAH patients (WHO FC II to III), provided the basis for the EC’s approval.
When comparing M/T STCT to the separate monotherapies, the study’s primary endpoint—a substantial reduction in pulmonary vascular resistance—was met.
