Otsuka receives CHMP backing for European Jinarc approval

Otsuka has announced that its new autosomal dominant polycystic kidney disease (ADPKD) therapy Jinarc has been recommended for European regulatory approval.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has endorsed the drug as a means of slowing the progression of cyst development and renal insufficiency of ADPKD in adults with chronic kidney disease stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease.

Developed over a period of 26 years at Otsuka's Japanese pharmaceutical research centre, the drug was first approved in Japan last year and in Canada last month. It would be the first available treatment for ADPKD in Europe if it is given the green light.

In a phase III clinical trial of patients with ADPKD, tolvaptan demonstrated a statistically significant reduction of 49 percent in the annual increase in total kidney volume versus placebo, and a reduction in the decline in kidney function by 30 percent.

Ole Vahlgren, chief executive officer and president at Otsuka Europe, said: "This recommendation brings us one step closer to providing to patients in Europe the first-in-the-world disease-modifying treatment for ADPKD, a progressive and chronic genetic disease."

The number of European patients affected by ADPKD is estimated to be around 205,000. A final approval decision on the drug is expected during the second quarter of 2015.