FDAnews Drug Daily Bulletin

Janssen NDA for Diabetes Combo Drug Draws Complete Response Letter

Dec. 16, 2013

Johnson & Johnson subsidiary Janssen said Thursday it received a complete response letter from the FDA regarding the company’s NDA for its canagliflozin/metformin fixed-dose combination therapy for adults with type 2 diabetes.

The FDA approved Janssen’s once-daily single-agent canagliflozin drug Invokana in March. The letter, however, asks for more information regarding the twice-daily dosing of canagliflozin present in the combination, Janssen says. “We’re going back to our original clinical trial data on Invokana to be able to supply the detail that they need to support the dosing,” spokeswoman Christina Holden told Drug Daily Bulletin. That Phase III data was drawn from 10,285 patients across nine studies.

Canagliflozin inhibits the carrier responsible for the reabsorption of glucose by the kidney, while metformin lowers the amount of glucose produced by the liver, according to the drugmaker. — Lena Freund

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