FDA rejects approval of AstraZeneca's Farxiga in type 1 diabetes

AstraZeneca announced Monday that the FDA issued a complete response letter regarding a filing seeking approval of Farxiga (dapagliflozin) as an adjunct treatment to insulin to improve glycaemic control in adults with type 1 diabetes, when insulin alone does not provide adequate glycaemic control. The oral, once-daily SGLT2 inhibitor was recently approved in this indication in Europe and Japan under the name Forxiga.

The submission in the US was based on data from two studies, with results from the DEPICT-1 trial demonstrating that after 24 weeks of treatment, both doses of Farxiga significantly lowered HbA1c compared with placebo, with mean reductions of 0.42% and 0.45% for the 5-mg and 10-mg doses, respectively. AstraZeneca said it will work closely with the FDA to discuss the next steps, without providing further details.

Farxiga is also indicated as both monotherapy and as part of combination therapy to improve glycaemic control as an adjunct to diet and exercise in adults with type 2 diabetes. The product generated sales of nearly $1.4 billion in 2018.

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