EC approves J&J’s Yuvanci for PAH

Following a positive a positive European Medicines Agency recommendation in July, the European Commission (EC) has now approved Yuvanci (macitentan 10mg and tadalafil 40mg single tablet combination therapy [M/T STCT]).

Developed by US healthcare giant Johnson & Johnson (NYSE: JNJ), Yuvanci is authorized as a substitution therapy for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, who are already treated with the combination of macitentan and tadalafil given concurrently as separate tablets.

J&J unit Janssen Cilag International noted that PAH is a rare, progressive and life-threatening blood vessel disorder, for which there is no cure. This approval of Yuvanci addresses a significant unmet need for the PAH community as, until now, no single tablet has been available for these patients in Europe and living with the condition required patients to take multiple pills a day, it said.