The FDAs Endocrinologic and Metabolic Drugs Advisory Committee
today voted 96 that dapagliflozin, the investigational sodium-glucose
co-transporter 2 inhibitor, should not be approved as an adjunct to diet and
exercise for the management of type 2 diabetes.
Several panel members noted that more data are needed, in light of
safety concerns linking
dapagliflozin (Bristol-Myers Squibb, AstraZeneca) with breast
and bladder cancers and drug-induced liver injury.
Further, although research did not suggest that dapagliflozin increases
risk for fracture or other negative effects on bone health, several panel
members noted that results from short-term trials, ranging 24 weeks to 2 years,
may not be long enough to properly assess this outcome. Possible adverse events
such as dehydration and imbalanced nutrition were also discussed, although the
panel generally felt these may not be significant.
Among those committee members who favored approval of dapagliflozin, the
consensus was that the
adequate amount of data required to accurately assess a
relationship between the drug and cancers and serious hepatic injury could not
be collected in postmarketing trials.
While the FDA is not required to follow the recommendations of the
advisory committee, it usually does.