Otsuka's Jinarc first ever drug to get EU approval for ADPKD

The European Commission has granted marketing authorization for Japanese drugmaker Otsuka Pharmaceutical’s (TYO: 4768) Jinarc (tolvaptan) for the treatment of autosomal dominant polycystic kidney disease (ADPKD) in adults who have chronic kidney disease (CKD) stage one to three at initiation of treatment with evidence of rapidly progressing disease.

In receiving this marketing authorization, tolvaptan becomes the first pharmaceutical therapy to be licensed in Europe for the treatment of the underlying pathophysiology of ADPKD. The drug gained a recommendation for approval from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) earlier this year (The Pharma Letter February 27). It was also cleared for marketing in Canada in February. Tolvaptan, under the trade name Samsca, was approved for this indication in Japan last year, and is under review with the US Food and Drug Administration.

“Significant medical breakthrough”