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AstraZeneca’s Farxiga fails to get FDA approval for patients with Type 1 diabetes

pharmafile | July 15, 2019 | News story | Sales and Marketing AstraZeneca, EMA, FDA, US, diabetes, farxiga 

The FDA had said it will not approve AstraZeneca’s diabetes drug Farxiga for use as a supplement to insulin in adults with Type 1 diabetes who haven’t been able to control their condition with insulin alone.

Farxiga is currently approved in the United States for adults with Type 2 diabetes, the more common form of the condition.

The US regulator has however declined to approve the drug for use in patients with Type 1 diabetes. AstraZeneca did not say what specific concerns had been raised by the FDA.

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The decision comes after the EMA approved Fraxiga, under the name Forxiga, for use in in patients with Type 1 diabetes earlier this year.

Type 1 diabetes (in which the pancreas produces little or no insulin) affects around 5% of all patients with diabetes.

Farxiga is one of AstraZeneca’s biggest selling drugs – the diabetes med having generated $1.39 billion in sales in 2018.

Louis Goss

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