Lilly receives FDA approval for diabetes treatment

Lilly and Boehringer Ingelheim have been granted approval from the US Food and Drug Administration  (FDA) for the investigational basal insulin treatment LY2963016, which has been developed to treat patients with type 1 and type 2 diabetes.

The new drug application was filed using the 505(b)(2) regulatory pathway and as a result, the FDA has been able to reference previous safety and efficacy data for insulin glargine products that have already been approved, adding this to the findings from studies of the LY2963016 drug. 

Having announced a diabetes alliance in January 2011, Lilly and Boehringer Ingelheim have designed a comprehensive development programme for the new insulin treatment, in an effort to ensure it meets the regulatory standards for clinical and non-clinical safety, efficacy and quality.

The companies presented the results from phase III trials conducted on patients with both type 1 and type 2 diabetes, using an alternative insulin glargine product that is already on the market as a comparison. 

LY2963016 is currently under review by the European Medicines Agency, with a view to gaining approval to market the drug across Europe.