Janssen-Cilag International NV, a Johnson & Johnson company, announced on September September 30, 2024, that the European Commission has approved Yuvanci®, a single tablet macitentan 10 mg and tadalafil 40 mg combination therapy for the long-term treatment of adult pulmonary arterial hypertension patients in WHO Functional Class II-III, who are treated with macitentan and tadalafil as separate tablets.
This EU Commission approval follows on from the recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), on July 26, 2024, to grant marketing authorisation.
The single tablet combination therapy was approved in the USA by the Food and Drug Administration (FDA) on March 2024 with the name Opsynvi – see our article at this link.