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news.Bristol-Myers Squibb and AstraZeneca have received complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding the new drug application (NDA) for Dapagliflozin as a treatment for type 2 diabetes in adults.
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Dapagliflozin, an inhibitor of SGLT2, is being investigated to assess the safety and efficacy in improving glycemic control in adults with type 2 diabetes, for use as a monotherapy and in combination with other anti-diabetic agents.
The complete response letter requests additional clinical data including data from ongoing studies and from new clinical trials to provide a better assessment of the benefit-risk profile for Dapagliflozin.
As part of the application procedures, both the companies will work closely with the FDA to determine the appropriate next steps for the Dapagliflozin application and discuss with health authorities in Europe and other countries.
The benefit-risk profile of the investigational medicine is evaluated from clinical development programs that included more than 8,000 adult patients with type 2 diabetes.
Bristol-Myers Squibb and AstraZeneca entered into a collaboration in January 2007 to enable the companies to research, develop and commercialize select investigational drugs for type 2 diabetes.