Janssen-Cilag International NV, a subsidiary of pharmaceutical giant Johnson & Johnson (JNJ), announced on Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has endorsed the Marketing Authorisation for Yuvanci. Yuvanci is a combination therapy consisting of Macitentan and Tadalafil, developed for the treatment of Pulmonary Arterial Hypertension (PAH).
PAH is a severe, progressive condition marked by the narrowing of small pulmonary arteries, increased blood pressure within the pulmonary circulation, and ultimately leading to right heart failure and mortality.
Yuvanci offers a single tablet combination therapy comprising macitentan 10 mg and tadalafil 40 mg (M/T STCT). It is intended as a substitution therapy for the long-term management of PAH in adult patients classified in WHO Functional Class (FC) II to III, who are already receiving both macitentan and tadalafil as separate tablets.
Pending approval from the European Commission, Yuvanci would become the sole single-tablet combination therapy available for PAH patients in Europe.
The CHMP's favorable opinion for M/T STCT is grounded in results from the Phase 3 A DUE study, which achieved its primary endpoint by demonstrating a significant change in pulmonary vascular resistance.
This positive opinion from the CHMP follows the U.S. Food and Drug Administration’s approval of OPSYNVI (another combination of macitentan and tadalafil) in March 2024 for the treatment of PAH patients.
