Mitsubishi Tanabe Pharma is seeking manufacturing and marketing approval of TA-7284 (generic name: canagliflozin) in Japan.
The company filed a new drug application to the Ministry of Health, Labor and Welfare in Japan for TA-7284 to treat patients with type 2 diabetes.
The efficacy and safety of canagliflozin were assessed during the Phase 3 programs, which involved testing more than 11,000 patients with type 2 diabetes from in and outside Japan.
Sodium glucose co-transporter 2 (SGLT2) inhibitor canagliflozin is an oral type 2 diabetes treatment discovered by Mitsubishi.
Canagliflozin works by inhibiting SGLT2, which is involved in the reabsorption of glucose in the renal tubule of the kidneys, suppresses reabsorption of glucose, promotes the loss of excessive glucose into the urine, and thereby improves glycemic control.
Janssen Pharmaceuticals, licensee, already gained NDA approval for canagliflozin to treat type 2 diabetes mellitus in the US and a marketing authorization application has been filed in Europe.
