AstraZeneca gets complete response from FDA over 'Farxiga'
AstraZeneca announced on Monday that the US Food and Drug Administration (FDA) has issued a complete response letter regarding the supplemental New Drug Application for ‘Farxiga’ (dapagliflozin) as an adjunct treatment to insulin to improve glycaemic control in adult patients with type-1 diabetes, when insulin alone does not provide adequate glycaemic control.
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The FTSE 100 pharmaceutical firm said it would work closely with the FDA to discuss the next steps.
It noted that Farxiga was recently approved in Europe at 5mg, and Japan at 5mg with a potential up-titration to 10mg, under the name ‘Forxiga’ as an adjunct to insulin in adults with type-1 diabetes.
“Farxiga (dapagliflozin) is a first-in-class, oral, once-daily selective inhibitor of SGLT2 indicated as both monotherapy and as part of combination therapy to improve glycaemic control, with the additional benefits of weight loss and blood-pressure reduction, as an adjunct to diet and exercise in adults with type-2 diabetes,” the AstraZeneca board said in its statement.
“Farxiga has a robust clinical trial programme of more than 35 completed and ongoing phase 2b and 3 trials with over 35,000 patients, as well as more than 1.8 million patient-years' experience.”
It said the ‘DEPICT’ - or Dapagliflozin Evaluation in Patients with Inadequately Controlled Type-1 diabetes - clinical trial programme consisted of two clinical trials, DEPICT-1 and DEPICT-2, which were 24-week, randomised, double-blinded, parallel-controlled trials designed to assess the effects of Farxiga 5mg or 10mg on glycaemic control in patients with type-1 diabetes, inadequately controlled by insulin.
All patients were evaluated at week 24 and after a 28-week extension, for 52 weeks in total.
The company described type-1 diabetes as a chronic disease in which the pancreas produced little or no insulin.
Approximately 5% of people living with diabetes had type-1.
The condition was caused by an autoimmune reaction, that destroyed the beta cells in the pancreas which produce insulin.
Different factors, including genetics and some viruses, could contribute to type-1 diabetes.