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Diabetes Drug Dapagliflozin Resubmitted for FDA Review
A new drug application (NDA) has been resubmitted to the FDA for dapagliflozin (AstraZeneca/Bristol-Myers Squibb), seeking approval for the treatment of adults with type 2 diabetes.
The NDA resubmission, which is pending acceptance by the FDA, includes several new studies and additional long-term data (up to 4 years’ duration) from previously submitted studies.
Dapagliflozin, an investigational compound, is a selective and reversible inhibitor of sodium-glucose co-transporter 2 (SGLT2), which works independently of insulin. The drug is currently approved for the treatment of type 2 diabetes in the European Union, Australia, Brazil, Mexico, and New Zealand.
In 2012, diabetes was estimated to affect more than 370 million people worldwide. The prevalence of diabetes is projected to reach more than 550 million by 2030. Type 2 diabetes accounts for approximately 90% to 95% of all cases of diagnosed diabetes in adults.
Source: AstraZeneca; July 25, 2013.