dapagliflozin

The approval comes a day after an FDA advisory panel voted 9-to-6 against a proposed diabetes drug, dapagliflozin, that is being codeveloped by Astra with Bristol-Myers Squibb Co. The FDA, however, still makes the final decision and isn't expected to rule until the end of October.

FDA Approves Astra's Anticlotting Drug Jennifer Corbett Dooren 2011

The drug, called dapagliflozin, has generated some interest among diabetes specialists because it has a novel mechanism of action that does not depend on influencing the production or use of insulin.

NYT > Home Page By ANDREW POLLACK 2012

Under the guidelines, even indirect financial links to a competitor barred Dr. Thomas from participating in an advisory panel for the diabetes pill, called dapagliflozin, without a waiver.

Reuters: Press Release 2011

Expectations for the drug, dapagliflozin, were already reduced because last year an FDA advisory committee recommended against its approval, citing concerns about potential safety risks.

Drug Setback for Bristol, Astra Peter Loftus 2012

Bristol and Astra said Thursday that the FDA has requested additional clinical data "to allow for a better assessment of the benefit-risk profile for dapagliflozin."

Drug Setback for Bristol, Astra Peter Loftus 2012

The company has had some R&D setbacks, including the U.S. Food and Drug Administration's recent decision not to approve experimental diabetes drug dapagliflozin because the agency wants more clinical data.

Bristol-Myers Net Rises 76% on Lower Taxes Peter Loftus 2012

The companies said they remain committed to the drug's development, and "will work closely with the FDA to determine the appropriate next steps for the dapagliflozin application."

Drug Setback for Bristol, Astra Peter Loftus 2012

Some analysts say the dapagliflozin may still have a chance of FDA approval, however.

Drug Setback for Bristol, Astra Peter Loftus 2012

Analysts said dapagliflozin's delay is a setback even though it isn't a major financial contributor for either company.

Drug Setback for Bristol, Astra Peter Loftus 2012

Earlier this month, Bristol-Myers's head of research, Elliott Sigal , said he was "pleased with interactions" with U.S. and European regulators regarding dapagliflozin.

Drug Setback for Bristol, Astra Peter Loftus 2012