Bristol-Myers Squibb and AstraZeneca announced
that, in a complete response letter to their new drug application for
dapagliflozin, the FDA asked for more clinical data to allow
a better assessment of the drug’s risk–benefit profile in light of safety concerns linking the drug with breast and bladder cancers and drug-induced liver injury.
The agency requested additional data from ongoing
clinical trials and may also require information from new studies, according to
a press release. The clinical development program upon which the manufacturers
based their application involved more than 8,000 adult patients with type 2
diabetes — 5,000 of whom were treated with dapagliflozin — in 19
Bristol-Myers Squibb and AstraZeneca said they will work
closely with the FDA to determine the appropriate next steps for the
dapagliflozin application. They are also in discussions with health authorities
in Europe and elsewhere as part of the application procedures.
Dapagliflozin, an SGLT-2 inhibitor, is being evaluated
as an adjunct to diet and exercise for treatment of adults with type 2
diabetes, and researchers are examining its use as both monotherapy and in
combined with other antidiabetic agents.