In Japan, Mitsubishi Tanabe files for canagliflozin approval; Eisai/AbbVie's Humira gets new indication

Japanese drug major Mitsubishi Tanabe Pharma (TYO: 4508) said yesterday (May 27) that it has submitted an application for the manufacturing and marketing approval of TA-7284 (canagliflozin), a sodium glucose co-transporter 2 (SGLT2) inhibitor, for the treatment of patients with type 2 diabetes, to the Japanese Ministry of Health, Labor and Welfare.

Canagliflozin, which has been discovered by Mitsubishi Tanabe, is an oral type 2 diabetes treatment with a novel mechanism of action. Canagliflozin inhibits sodium glucose co-transporter 2 (SGLT2), a transporter involved in the re-absorption of glucose in the renal tubule of the kidneys, suppresses re-absorption of glucose, promotes the loss of excessive glucose into the urine, and as a result, improves glycemic control.

More than 11,000 patients with type 2 diabetes were enrolled in the Phase III programs in and outside Japan, which assessed the efficacy and safety of canagliflozin. The development program included mono-therapy adjunct to diet and exercise, combination therapies with other anti-hyperglycemic agents such as DPP-4 inhibitors, insulin and also involved type 2 diabetes patients with impaired renal function, those who have or are at high risk of developing cardiovascular disease and elderly patients.