AstraZeneca announced yesterday that the U.S. Food and Drug Administration (FDA) did not approve its diabetes treatment, Farxiga, for use as a supplement to insulin in adults with Type 1 diabetes.
The FDA issued the drugmaker a complete response letter regarding the supplemental New Drug Application (sNDA) for Farxiga.
AstraZeneca was seeking approval for the drug 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.
Farxiga is already approved in the United States for use in Type 2 diabetes. The company plans to work with the FDA to discuss the next steps.
Farxiga was recently approved in Europe (5mg) and Japan (5mg, potential up-titration to 10mg) under the name Forxiga, as an adjunct to insulin in adults with Type 1 diabetes.
- AstraZeneca. (2019, July 15). Update on US regulatory decision for Farxiga in type-1 diabetes. Retrieved July 16, 2019, from https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/update-on-us-regulatory-decision-for-farxiga-in-type-1-diabetes-15072019.html