Monday, December 23, 2013
FDA's second review of dapagliflozin from Bristol-Myers
Squibb Co. and AstraZeneca
plc shows the agency is still on the hunt for any sign of potential CV
risk for diabetes candidates - even when they clear the statistical hurdle
outlined in 2008 guidance. The Endocrinologic and Metabolic Drugs Advisory
Committee, however, appears to have swung back to center in its consideration
of risk to benefit ratios.
The first time around, the
issue that stymied dapagliflozin was cancer, not cardiovascular risk. In 2011,
the panel voted 9-6 against approval, and FDA issued a complete response letter
for dapagliflozin, due primarily to an imbalance in breast and bladder cancers,
as well as a single case of hepatotoxicity in the clinical program (see
BioCentury, July 25, 2011).