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