BMS, AZ take step toward blockbuster approval

Bristol-Myers Squibb and AstraZeneca won a crucial FDA expert panel vote backing their diabetes blockbuster saxagliptin.

The panel voted 10 to 2 that the drug did not carry excess cardiovascular risk, a key endorsement for a drug that now has a big leg up in gaining a final approval. If it is approved, analysts project that saxagliptin will present significant competition to Merck's Januvia. The FDA has outlined tougher safety standards for diabetes drugs following the revelation that Avandia increased the risk of heart attacks.

The developers, though, aren't off the hook for a post-approval study. Brian Daniels, Bristol's senior vice president of global development and medical affairs, told the Wall Street Journal that a large outcomes study is already being designed.

- read the report from the Wall Street Journal

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