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AstraZeneca’s sNDA for Farxiga as Adjunct for Type 1 Diabetes Denied by FDA

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AstraZeneca’s sNDA for Farxiga as Adjunct for Type 1 Diabetes Denied by FDA

AstraZeneca announced the U.S. FDA issued a Complete Response Letter to a supplemental New Drug Application (sNDA) for Farxiga (dapagliflozin) as an adjunct treatment to insulin for type 1 diabetes (T1D) when insulin alone doesn’t keep blood sugar levels under control. AstraZeneca did not disclose the rationale for the Complete Response Letter but did indicate it planned to initiate discussions with the FDA on next steps.

The sNDA included date from the DEPICT clinical trial program, made up of two clinical trials, DEPICT-1 and DEPICT-2. These 24-week, randomized, double-blinded, parallel-controlled trials are designed to assess Farxiga 5mg or 10mg doses on glycemic control in T1D patients inadequately controlled by insulin. All patients were evaluated at week 24 and after a 28-week extension (52 weeks in total). Data showed that Forxiga 5mg daily, when given as an oral adjunct to adjustable insulin in patients with inadequately-controlled T1D, demonstrated significant and clinically-meaningful reductions from baseline in average blood glucose levels HbA1c (primary endpoint), weight and total daily insulin dose (secondary endpoints) at 24 and 52 weeks.

The drug was recently approved in both Europe and Japan under the name Forxiga for type 1 diabetes.

Farxiga is approved in the U.S. for type 2 diabetes. 

 

About Type 1 Diabetes.     ez

Type 1 diabetes affects about 5% of patients with diabetes and is a condition where the pancreas produces little or no insulin. It is caused by an autoimmune reaction that results in destroyed beta cells in the pancreas. These are the cells that produce insulin. Viruses and genetic factors also play a role.

 

About Farxiga (dapagliflozin)

Farxiga (dapagliflozin) is an oral once-daily selective inhibitor of human sodium-glucose co-transporter 2 (SGLT2).

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