AstraZeneca: FDA denies approval for type-1 diabetes pill

(CercleFinance.com) - AstraZeneca said U.
S. health regulators declined to approve its oral drug Farxiga for the treatment of patients with type-1 diabetes.

The US Food and Drug Administration (FDA) has issued a complete response letter regarding its supplemental new drug application for the pill 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, the Anglo-Swedish drugmaker said.

AstraZeneca said it will work closely with the FDA to discuss the next steps of the process.

Farxiga was recently approved in Europe and Japan as an adjunct to insulin in adults with type-1 diabetes.

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