Treatment for ADPKD approved in Canada

JINARC® (tolvaptan) has been approved in Canada as a treatment for autosomal dominant polycystic kidney disease (ADPKD). JINARC® was discovered in Japan by Otsuka Pharmaceutical and was first approved there for ADPKD in 2014. The Health Canada approval of JINARC® is based on the results of the pivotal Phase 3 randomized, double-blind and placebo-controlled TEMPO 3:4 Trial, the largest study conducted to date in adults with ADPKD.

We are very excited for our ADPKD patients in Canada to have access to a treatment that slows the progression of kidney enlargement. For patients in the United States, we are hopeful this is within reach as well. Otsuka Pharmaceutical Development & Commercialization, Inc. and the United States Food & Drug Administration (FDA) have been working together to determine the most appropriate path forward. Initially, in late August of 2013, Otsuka received a Complete Response Letter (CRL) from the FDA regarding tolvaptan to treat adult patients with ADPKD. The FDA issues CRLs to convey that their initial review of a new drug application is complete and they cannot approve it in its present form without additional information.

In June 2014, Otsuka announced that patient enrollment began for a new Phase 3b study of tolvaptan for adult patients with ADPKD. The company reached an agreement with the FDA on a Special Protocol Assessment (SPA) for the design and planned analysis of this trial. This Phase 3b trial is being conducted to provide the additional information requested by the FDA.

Patients play a key role in developing treatments by volunteering to participate in clinical studies. Learn more about getting involved in this and other trials.

Read the press release to learn more information about this announcement, including contact information for questions.

Read the announcement from the PKD Foundation of Canada