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.

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