AstraZeneca’s Farxiga fails to get U.S. approval for Type-1 diabetes

 

(Reuters) – British drugmaker AstraZeneca Plc said on Monday the U.S. Food and Drug Administration declined to approve its diabetes treatment, Farxiga, for use as a supplement to insulin in adults with a rare type of the condition.

The company said the regulator issued a complete response letter, declining its application for using the drug in patients with Type-1 diabetes where insulin alone has not been able to control blood sugar levels.

Farxiga is already approved in the United States for use in Type-2 diabetes.

 

(Reporting by Pushkala Aripaka in Bengaluru; Editing by Arun Koyyur)

 

Reuters source:

https://www.reuters.com/article/astrazenecas-farxiga-fails-to-get-fda-ap/astrazenecas-farxiga-fails-to-get-fda-approval-for-type-1-diabetes-idUSL4N24G19U