Posted by Michael Wonder on 10 Nov 2017
FDA accepts Otsuka's resubmission to support a regulatory review of tolvaptan in the treatment of ADPKD
9 November 2017 - Tolvaptan has been studied in patients with autosomal dominant polycystic kidney disease in a clinical trial program which included more than 3,165 trial participants exposed to at least one dose of tolvaptan across 18 trials.
Otsuka announces that the U.S. FDA has accepted Otsuka’s resubmission to support a regulatory review of Otsuka’s new drug application for tolvaptan in the treatment of adults with Autosomal Dominant Polycystic Kidney Disease (ADPKD).
Otsuka’s resubmission is a response to the complete response letter that FDA issued in August 2013. The FDA considers the resubmission to be filed as of 24 October 2017, with a PDUFA action date of 24 April 2018.
The application for the proposed indication for tolvaptan in adults with ADPKD is supported by an extensive clinical trial program.
