FDA Staff Express Concern over Experimental AstraZeneca/BMS Diabetes Drug
The U.S. Food and Drug Administration (FDA) announced that it is still unsure whether the benefits associated with AstraZeneca’s and Bristol-Meyers Squibb’s (BMS) experimental diabetes drug dapagliflozin outweigh the drug’s risks.
FDA to Review AstraZeneca /BMS Diabetes Drug
“As a result of these updated analyses the agency could not conclude with any level of confidence that the purported CV (cardiovascular) benefit associated with dapagliflozin outweighed the observed imbalance in specific malignancies or potential liver toxicity risks.” – FDA release as published by Reuters
According to Reuters, documents posted on the FDA’s website suggest that the agency may still have doubts on whether AstraZeneca and Bristol-Meyers Squibb will gain marketing approval for their new diabetes drug, dapagliflozin.
Originally set for approval in January 2012, the FDA knocked back the approval following concerns that the possible risk of bladder cancer or liver damage observed during clinical trials outweighed any cardiovascular benefits granted by the drug.
An advisory committee meeting is scheduled for this week, Thursday, but approval for the drug is now the subject of speculation as the FDA acknowledges that even the latest evidence presents a mixed bag in terms of a benefit/risk comparison.
- Dapagliflozin is a new kind of drug designed to treat Type 2 diabetes by allowing more sugar to be excreted with urine.
- The drug has been approved in Europe under the brand name Forxiga – U.S. approval is currently pending.
- If approved, the drug would become the second SGLT2 inhibitor on the market following Johnson and Johnson’s Invokana (canagliflozing) which was approved in March.
- Reuters analysts project sales for dapagliflozin to reach $806 million by 2019.
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