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EMA committee recommends approval of Xigduo

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AstraZeneca and Bristol-Meyers Squibb announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use supports the approval of combination dapagliflozin and metformin for treatment of adults with type 2 diabetes, according to a press release.

The treatment (Xigduo, AstraZeneca and Bristol-Myers Squibb) is a tablet designed to be taken twice daily to improve glycemic control in patients whose current metformin-based treatment regimen is inadequate or in those taking a combination of dapagliflozin and metformin as separate tablets.

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