FORXIGA (dapagliflozin) receives positive CHMP opinion in the EU for the treatment of type 2 diabetes

AstraZeneca and Bristol-Myers Squibb Company today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of FORXIGA (dapagliflozin) tablets for the treatment of type 2 diabetes, as an adjunct to diet and exercise, in combination with other glucose-lowering medicinal products including insulin, and as a monotherapy in metformin intolerant patients.

Dapagliflozin is an investigational selective and reversible inhibitor of sodium-glucose co-transporter 2 (SGLT2), which works independently of insulin. This is the first in the new SGLT2 class to receive a positive CHMP opinion for the treatment of type 2 diabetes, a disease where high unmet medical need exists.

The positive opinion was reached after the CHMP reviewed data from a comprehensive clinical development programme that included 11 core Phase III trials assessing the safety and efficacy of dapagliflozin as a once-daily oral therapy. These trials involved 5,693 patients with type 2 diabetes, including 3,939 patients treated with dapagliflozin.

Dapagliflozin 10mg is intended as a once-daily oral dose in adult patients with type 2 diabetes to improve glycaemic control:

• As a monotherapy, when diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance;
• In combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.

David Brennan, Chief Executive Officer, AstraZeneca, said: “We are pleased the CHMP has given a positive assessment of the benefit/risk profile of this novel product in a new class for the treatment of type 2 diabetes, an area of high unmet medical need.”

The CHMP’s positive opinion on dapagliflozin will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.