Janssen R&D announced that it has received a Complete Response Letter from the FDA for its New Drug Application (NDA) for the fixed-dose combination (FDC) of canaglifozin and immediate-release metformin to treat adults with type 2 diabetes.
The FDA has requested that Janssen R&D provide 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.
Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that blocks the reabsorption of glucose in the kidney, increases glucose excretion, and lowers blood glucose levels. Metformin is a first-line oral medication that lowers blood glucose levels by decreasing the amount of glucose made by the liver.
Previously in March 2013, the FDA approved Invokana (canagliflozin) as a single agent as an adjunct to diet and exercise to lower blood sugar in adults with type 2 diabetes.
For more information call (800) 526-7736 or visit JanssenRnD.com.