EU regulator backs approval of AstraZeneca, Bristol-Myers Squibb's Forxiga for diabetes

AstraZeneca and Bristol-Myers Squibb said Friday that European regulators backed approval of Forxiga (dapagliflozin) for the treatment of type 2 diabetes. The companies noted that the drug is the first in the SGLT2 class to receive a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in this indication.

Specifically, the once-daily compound is recommended 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 patients who are intolerant to metformin.

The company noted that the CHMP reached its decision after reviewing data from 11 late-stage studies involving 5693 patients with type 2 diabetes, including 3939 patients who were treated with Forxiga. The regulator said that in these trials, AstraZeneca and Bristol-Myers Squibb's drug improved glycaemic control when given alone or in combination with other diabetes medicines, with effects similar to those of glipizide and metformin. The EMA added that the effect of Forxiga appeared to be maintained for up to 102 weeks.

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