FDA asks for more data on dapagliflozin

AstraZeneca (OMXS: AZN) and Bristol-Myers Squibb have received a complete response letter from US Food and Drug Administration FDA regarding SGLT2 inhibitor dapagliflozin, a drug candidate for type 2 diabetes in adults. The FDA requests additional clinical data to be able to assess the benefit-risk profile of the compound. This may also require additional clinical trials. So far over 8000 adult patients have been on dapagliflozin trials and the companies aim to continue to push ahead.

Last July an FDA advisory panel voted 6-9 against the approval of dapagliflozin after a lively debate on whether more data should be obtained pre- or post approval. In October the PDUFA date was extended by three months as the companies said to provide more data from recently completed and ongoing studies, raising some hopes for a different outcome. AstraZeneca has shed 2% for the day.