Janssen Research & Development, LLC (Janssen) today announced it has received from the U.S. Food and Drug Administration (FDA) a complete response letter regarding its New Drug Application (NDA) for a fixed-dose combination (FDC) of canagliflozin and immediate-release metformin to treat adults with type 2 diabetes.
The complete response letter related to the NDA requested additional information 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 3 clinical development program for canagliflozin.
"We continue to have productive discussions with the FDA and will work closely with the agency to advance this application," said Norman Rosenthal, MD, FACE, FACP, canagliflozin compound development team leader, Janssen Research & Development, LLC. "We look forward to addressing questions from the FDA as soon as possible and remain committed to providing therapeutic options that meet the needs of the type 2 diabetes community."