The U.S. Food and Drug Administration has delayed making a decision over Bristol-Myers Squibb Co. (NYSE: BMY) and AstraZeneca‘s (NYSE: AZN) jointly developed Type 2 diabetes drug, dapagliflozin, until the start of 2012 , after an advisory committee recommended against approving the drug in July over safety concerns tied to bladder cancer in phase 2b and phase 3 clinical trials.
The new Prescription Drug User Fee Act goal date is Jan. 28, 2012.
The drug companies said they will would provide data on dapagliflozin from recently completed and ongoing phase 3 clinical trials in response to an FDA request , the release said, in what was described as “a major amendment to the original new drug application (NDA) for dapagliflozin.”
“Bristol-Myers Squibb and AstraZeneca are committed to dapagliflozin as a potential new therapeutic option for adults with type 2 diabetes,” said Brian Daniels, M.D., senior vice president of global development and medical affairs for Bristol-Myers Squibb. “We will continue to work closely with the FDA to support the continued review of the NDA.”
The once daily pill aimed at helping diabetics flush out excess sugar from their urine would be the first in a new class of insulin independent drugs.
The delay reflects an FDA much more inclined to caution following Glaxo Smith Kline’s experience with Avandia. In a more vigorous regulatory climate, the process of getting diabetes drugs approved has slowed down, prompting some companies to shelve their programs rather than pursuing what can be a costly pipeline to approval.
And yet, for the drug companies that can afford it, diabetes drugs represent a potentially lucrative market in the face of rising obesity and represent a critical area for expansion.
