Posted by: Pulse Clinical Team23 September 2013
The European Medicines Agency (EMA) has endorsed canagliflozin the second in the latest type 2 diabetes drug class - the sodium-glucose co-transporter 2 (SGLT2) inhibitors.
The EMA's Committee for Medicinal Products for Human Use issued a positive opinion on the drug last week and formal approval is expected within 60 days.
The indication recommended is for use as monotherapy in adults with type 2 diabetes when diet and exercise do not provide adequate glycemic control and metformin is contraindicated or cannot be tolerated. 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.
Last November dapagliflozin became the first SGLT2 inhibitor to be approved in Europe. But canagliflozin is the only such drug to be approved in the US as the Food and Drug Administration rejected dapagliflozin because of concerns about a cancer signal. It is due to be considered by the FDA again early next