Johnson & Johnson has filed the investigational diabetes drug canagliflozin with regulators in the USA.
J&J's Janssen unit has submitted a New Drug Application to the US Food and Drug Administration seeking approval for the use of canagliflozin, which is an oral, once-daily, selective sodium glucose co-transporter 2 (SGLT2) inhibitor, for the treatment of adults with type 2 diabetes. The filing is supported by nine clinical studies that enrolled some 10,300 patients.
The Phase III programme evaluated canagliflozin in placebo- and active comparator-controlled studies and included a dedicated cardiovascular study to comply with criteria outlined in the FDA's December 2008 guidance for new antidiabetic drugs. Janssen will present data from the Phase III studies at future congresses, beginning with the scientific sessions of the American Diabetes Association in Philadelphia later this month.
J&J says that the studies "represent the largest late-stage development programme for an investigational pharmacologic product for the treatment of patients with type 2 diabetes submitted to health authorities to date". Canagliflozin blocks the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels and belongs to the same class as AstraZeneca/Bristol-Myers Squibb's Forxiga (dapagliflozin).
The latter has recently been recommended for approval in Europe, although earlier this year the FDA issued a complete response letter for dapagliflozin, and requested additional data from ongoing studies amid concerns of possible liver damage and a potential link with breast and bladder cancer.
Canagliflozin was licensed from Japan's Mitsubishi Tanabe Pharma Corp and Janssen has marketing rights in North and South America, Europe, Middle East, Africa, Australia, New Zealand and parts of Asia.