The drug is used in additon to diet and exercise and in combination with insulin and other products that lower glucose. It is the first of a new class of drugs to receive a recommendation from the committee.
The recommendation came after Phase III trials that involved nearly 5,700 patients. The tablet is taken once daily.
David Brennan, Chief Executive Officer, AstraZeneca, said: “We are pleased the CHMP has given a positive assessment of the benefit/risk profile of this novel product in a new class for the treatment of type 2 diabetes, an area of high unmet medical need.”
The positive opinion on dapagliflozin will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.
At the end of 2011, diabetes was estimated to have affected nearly 53 million people aged 20-79 in Europe, and this figure is projected to rise to more than 64 million by 2030.
Bristol-Myers Squibb and AstraZeneca entered into a collaboration in January 2007 to enable the companies to research, develop and commercialize select drugs for type 2 diabetes.
AstraZeneca is based in London and has research, manufacturing and administrative operations in northern Delaware.