FDA panel advises against approval of dapagliflozin

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee today voted 9–6 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.

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The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee today voted 9–6 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.

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