AstraZeneca Plc (AZN,AZN.L) and Bristol-Myers Squibb Co. (BMY) 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.
Dapagliflozin is an investigational selective and reversible inhibitor of sodium-glucose co-transporter 2, which works independently of insulin.
The companies noted that 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.
by RTT Staff Writer
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