AstraZeneca and Bristol-Myers Squibb Company announced today that the US Food and Drug Administration (FDA) has extended the action date for dapagliflozin for the treatment of type 2 diabetes by three months. The new Prescription Drug User Fee Act (PDUFA) goal date is 28 January 2012.
In response to an FDA request for additional data on dapagliflozin, Bristol-Myers Squibb and AstraZeneca are submitting data from recently completed and ongoing Phase III clinical trials.
This data submission constitutes a major amendment to the original new drug application (NDA) for dapagliflozin.
Dapagliflozin, an inhibitor of the SGLT2 target in the kidney, is under joint development by Bristol-Myers Squibb and AstraZeneca as an adjunct to diet and exercise.
It is being investigated by the two drug giants to evaluate its safety and its effect on blood sugar levels (glycosylated hemoglobin levels, or HbA1c), in adults with type 2 diabetes, for use as a monotherapy and in combination with other anti-diabetic agents.
Type 2 diabetes accounts for approximately 90 per cent to 95 per cent of all cases of diagnosed diabetes in adults. Type 2 diabetes is a chronic, progressive disease characterised by insulin resistance and / or dysfunction of beta cells in the pancreas, which decreases insulin sensitivity and secretion, leading to elevated glucose levels.
Bristol-Myers Squibb and AstraZeneca entered into a collaboration in January 2007 to enable the companies to research, develop and commercialise select investigational drugs for type 2 diabetes. The Bristol-Myers Squibb/AstraZeneca Diabetes collaboration is dedicated to global patient care, improving patient outcomes and creating a new vision for the treatment of type 2 diabetes.