Janssen Research & Development, LLC, a Johnson & Johnson subsidiary, has received from a complete response letter (CRL) from the FDA regarding its NDA for a fixed-dose combination (FDC) of canagliflozin and immediate-release metformin to treat adults with type 2 diabetes.

The CRL 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 III clinical development program for canagliflozin.

Canagliflozin is an oral medication that selectively inhibits sodium glucose co-transporter 2 (SGLT2), a carrier responsible for the reabsorption of glucose by the kidney, thereby promoting the loss of glucose in the urine and lowering blood glucose levels in adults with type 2 diabetes. Metformin is a first-line oral medication that can be used alone or with other medications, including insulin, to treat type 2 diabetes. Metformin lowers blood glucose levels by decreasing the amount of glucose made by the liver.

If approved, the canagliflozin and metformin fixed-dose combination could provide convenience for patients who may benefit from the two diabetes medications in one tablet. Janssen submitted the NDA for the canagliflozin/metformin FDC on December 12, 2012.

In March 2013, the FDA approved canagliflozin as a single agent as an adjunct to diet and exercise to lower blood sugar in adults with type 2 diabetes.