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AstraZeneca’s Farxiga Fails To Get FDA OK As Insulin Supplement In Type 1 Diabetes

 
• By Sten Stovall

The UK pharma said the FDA had issued a complete response letter, declining its application for using Farxiga in the new T1D indication. Analysts suspect worries over diabetic ketoacidosis risk lie behind the rejection.

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The FDA’s CRL will have said the Farxiga application cannot be approved in its present form • Source: Shutterstock

AstraZeneca PLC on 5 July said the US Food and Drug Administration declined to approve its diabetes treatment Farxiga as a supplement to insulin in adults with type 1 diabetes, fanning fresh doubts about use of SGLT2 inhibitors as a treatment for the condition.

In a tersely worded statement, AstraZeneca said it had received a complete response letter from the FDA in reply to its supplemental marketing application for Farxiga, effectively rejecting it as an adjunctive treatment to insulin to improve glycemic control in adults

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