EU Gives Green Light to Canagliflozin for Diabetes

Lisa Nainggolan

September 20, 2013

The European Medicines Agency (EMA) has endorsed canagliflozin (Invokana, Janssen Pharmaceuticals), a sodium-glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.

The EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the product this week, at its September meeting. This is tantamount to a recommendation for approval, with formal approval by the European Commission normally following within 60 days.

The indication recommended by the CHMP for canagliflozin is for use as monotherapy in adults with type 2 diabetes when diet and exercise do not provide adequate glycemic control and patients can't tolerate metformin or the latter is contraindicated. Canagliflozin is also recommended for add-on therapy with other glucose-lowering mediations, including insulin, when these, together with diet/exercise, do not provide adequate glycemic control.

SGLT2 inhibitors prevent the reabsorption of glucose from the kidneys back into the blood, leading to increased glucose in the urine and reduced glucose levels in the blood.

Canagliflozin will not be the first SGLT2 inhibitor available in Europe. Dapagliflozin (Forxiga, Bristol-Myers Squibb/AstraZeneca) was approved there last November.

But canagliflozin is currently the only SGLT2 inhibitor approved for diabetes in the United States, with the Food and Drug Administration (FDA) having rejected dapagliflozin because of concerns about a cancer signal. Dapagliflozin is due to be considered by the FDA again early next year.

Other SGLT2 inhibitors in development include empagliflozin (Boehringer Ingelheim/Lilly), which is in phase 3 trials and has just been filed for approval in the United States, and ipragliflozin (Astellas Pharma) and luseogliflozin (Taisho Pharmaceutical), which are awaiting approval in Japan.

Further back in clinical trials are tofogliflozin (Chugai Pharma), which is in phase 3 studies, and ertugliflozin (Pfizer/Merck), which is expected to begin phase 3 trials later this year.

An editorial published in the Lancet this summer noted that the position of SGLT2 inhibitors in the stepwise treatment of type 2 diabetes "is currently unclear," but ongoing clinical trials "will help better establish the place of these agents."