Johnson & Johnson has filed for approval of its candidate type 2 diabetes drug canagliflozin in the US, giving it a chance to be the first to market in a new therapeutic class.
Canagliflozin is a selective sodium glucose co-transporter 2 (SGLT2) inhibitor, which blocks the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels.
The drug is in the same class as AstraZeneca/Bristol-Myers Squibb's Forxiga (dapagliflozin), which was knocked back by the FDA at its first filing attempt, with the agency asking for more clinical data earlier this year in order to complete its review.
Specifically, the panel questioned the safety of dapagliflozin with regard to a potential link to bladder/breast cancer, and said additional data from a large-scale outcomes study would be desirable. AZ and BMS were unable to satisfy the agency's requirements by the FDA's extended review deadline of January 28, 2012, and it has been suggested that the two firms may need to conduct additional trials before they can re-file.
That setback has given J&J's Janssen subsidiary and development partner Mitsubishi Tanabe a chance of getting to market first with canagliflozin, assuming the issues raised with dapagliflozin are not considered to be mechanism-related and therefore class effects.
Janssen said its application contains data from nine clinical trials, which enrolled more than 10,000 patients and is claimed to be the largest-ever late-stage development programme for an investigational drug for type 2 diabetes.
The phase III programme "evaluated the safety and efficacy of canagliflozin across the spectrum of type 2 diabetes and included placebo- and active comparator-controlled studies," said J&J in a statement.
J&J has also said it intends to file canagliflozin for European approval in the coming months. AZ and BMS were scheduled to file for EU approval of dapagliflozin in the latter half of the year, but it is unclear whether this will be an option given the FDA's verdict.
Also coming through the SGLT2 inhibitor pipeline is Boehringer Ingelheim/Eli Lilly's empagliflozin, which is in phase III trials and has been slated for a potential launch in 2014.