FDA wants more data from AstraZeneca on diabetes drug

19th Jan 2012 07:27

AstraZeneca says the US Food and Drug Administration (FDA) wants more clinical data on its dapagliflozin treatment for type 2 diabetes in adults.Astra is developing the therapy with US firm Bristol-Myers Squibb and says it has already conducted 19 clinical trials with 8000 adults.The FDA, however, wants more data to assess the "benefit-risk" profile of the drug, which Astra says "includes clinical trial data from ongoing studies and may require information from new clinical trials."AstraZeneca and Bristol-Myers Squibb say they "remain committed to dapagliflozin" and will work with the FDA to provide the data.AstraZeneca shares have outperformed the FTSE 100 over the last 12 months, gaining 4% against a loss of 5% for the index overall.BS