EU Agency Endorses Dapagliflozin Diabetes Drug

European regulators backed approval of a new diabetes drug from AstraZeneca and Bristol-Myers Squibb, in a decision that contrasts with its failure to win approval in the US….

Dapagliflozin belongs to a new class of diabetes drugs designed to allow more sugar to be excreted with urine and has the potential to be the first to treat the disease independent of the hormone insulin.

Dapagliflozin’s recommended indication is as an adjunct to diabetes and exercise in patients with type 2 diabetes — either in combination with other glucose-lowering drugs, including insulin, or as monotherapy in patients who cannot take metformin.

The favorable opinion stands in contrast to that of the FDA’s advisory committee on endocrinologic drugs, which voted 9-6 last year against approval. The panel decided that excess cases of breast and bladder cancer in patients receiving the drug in clinical trials were too worrisome without additional data.

In January, the FDA sent AstraZeneca and Bristol a complete response letter that requested additional data before it would consider approving dapagliflozin.

U.S. experts had raised concerns over the risk of cancer and liver injury associated with the medicine, prompting the U.S. FDA to issue a so-called “complete response letter” in January asking for more clinical data.

The green light for dapagliflozin from the European Medicines Agency (EMA) will now go to the European Commission for formal approval, a process that normally takes a couple of months.

European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use, April, 2012.