Bristol-Myers Squibb (NYSE:BMY) and AstraZeneca’s (NYSE:AZN) jointly developed treatment for type 2 diabetes has been turned down by U.S. regulators until lingering questions over the diabetes drug’s benefits and risks are addressed.
The U.S. Food and Drug Administration has requested additional clinical data on dapagliflozin to better assess the benefit-risk profile for the drug, including clinical trial data from ongoing studies and possibly from new clinical trials, according to statements from Princeton, New Jersey-based Bristol-Myers Squibb and AstraZeneca in Wilmington, Delaware acknowledging they had received a complete response letter.
“Bristol-Myers Squibb and AstraZeneca will work closely with the FDA to determine the appropriate next steps for the dapagliflozin application, and are in ongoing discussions with health authorities in Europe and other countries as part of the application procedures,” the statement said.
The FDA had delayed making a decision about the drug last October following an FDA advisory regulatory committee recommendation to reject approval of dapagliflozin in July over safety concerns tied to bladder cancer in phase 2b and phase 3 clinical trials.
More than 300 million people have diabetes, according to the World Health Organization. Drugmakers have been developing for novel kinds of treatments to address anticipated increases in people with the disease as obesity numbers rise.
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. Other drug companies such as Johnson & Johnson (NYSE:JNJ) and Eli Lilly & Co. (NYSE:LLY) are also developing insulin-independent drugs.
But a research note from Bernstein analyst Tim Anderson has said the diabetes drug market is already crowded without adding dapagliflozin to the mix:
“The drug has had little support from diabetes experts and the diabetes field is already crowded with a host of different therapeutic options, many of which are now available generically.”