US FDA calls for more data on Janssen’s fixed dose diabetes drug

16 December 2013

US health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Research & Development has received a complete response letter from the Food and Drug Administration regarding its New Drug Application for a fixed-dose combination (FDC) of canagliflozin and immediate-release metformin to treat adults with type 2 diabetes requesting additional information.

The agency requires data to support the comparability of the twice-daily dosing regimen of canagliflozin - as part of the canagliflozin and metformin FDC - and the once-daily dosing of canagliflozin as a single agent. Janssen believes it can supply this information based on available clinical data from the comprehensive Phase III clinical development program for canagliflozin.

Will work with agency to advance NDA

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