AstraZeneca PLC, Bristol-Myers Squibb Company Say FORXIGA Gets Positive CHMP Opinion in EU

Published: Apr 23, 2012

AstraZeneca Plc (AZN: News ,AZN.L: News ) and Bristol-Myers Squibb Co. (BMY: News ) said that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency 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. 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.

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