U.S. drug regulators need further clinical data, possibly including new clinical studies, before approving a new diabetes drug from AstraZeneca and Bristol-Myers Squibb, Reuters reported. The two companies said on Thursday they had received a so-called "complete response letter" from the Food and Drug Administration (FDA) for dapagliflozin as a treatment for type 2 diabetes in adults. The news is a setback for both drugmakers, compounding other recent pipeline disappointments in cancer for Bristol, and both cancer and depression for AstraZeneca. The two partners said they remained committed to dapagliflozin and its development but the FDA decision further dims prospects for the once-a-day drug, which is seeking to compete in an already well-supplied diabetes market. Shares in AstraZeneca, which is struggling to find new drugs to replace a wave of those going off patent, fell 1.2 percent by 0900 GMT, underperforming a flat European drugs sector. Stock in Bristol, which has a smaller established sales base and has been more aggressive in talking up prospects for dapagliflozin, fell 6 percent in trading in Germany. Hopes for dapagliflozin have dwindled since July, when an FDA panel of outside experts voted against recommending approval over concerns about cancer risks and liver injury. The panel said at the time it did not think clinical data provided enough certainty about the drug's safety. FDA staff have been pondering dapagliflozin's future since then. Regulators have become more cautious about new diabetes drugs following a past controversy over GlaxoSmithKline's Avandia, which was linked to heart risks. The agency was originally due to decide on dapagliflozin in October but the deadline was then pushed back to Jan. 28. -- SPA
