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Bristol-Myers Squibb and AstraZeneca receive CHMP backing for diabetes drug
Bristol-Myers Squibb and AstraZeneca's new diabetes therapy Xigduo has been recommended for European regulatory approval by the Committee for Medicinal Products for Human Use (CHMP).
The European Medicines Agency committee has issued a positive opinion on the use of Xigduo to improve glycaemic control in adult type 2 diabetes patients who are inadequately controlled on their current metformin-based treatment regimen, or who are currently being treated with the combination of dapagliflozin and metformin as separate tablets.
Xigduo combines the SGLT2 inhibitor dapagliflozin – which is sold under the brand name Forxiga – and metformin hydrochloride in a twice-daily tablet. This represents the first CHMP recommendation given to a combination therapy of this kind.
The CHMP's decision will now be reviewed by the European Commission, which will be responsible for deciding whether the new drug will receive a final approval.
This comes after Bristol-Myers Squibb recently marked World Diabetes Day by providing funding for four US-based diabetes research projects, which will analyse the link between type 2 diabetes, depression and distress.
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