INDIANAPOLIS (dpa-AFX) - Eli Lilly and Co (LLY) said Monday the U.S. Food and Drug Administration granted tentative approval for Basaglar (insulin glargine injection), which is indicated to improve glycemic control in adults with type 2 diabetes and in combination with mealtime insulin in adults and pediatric patients with type 1 diabetes.
Basaglar is Eli Lilly and Boehringer Ingelheim's basal insulin, which is intended to provide long-lasting blood sugar control in between meals and during the night.
With a tentative approval, the FDA has determined that Basaglar meets all of the regulatory requirements for approval, but it is subject to an automatic stay of up to 30 months as a result of litigation filed by Sanofi (SNY), claiming patent infringement.
The tentative approval is based, in part, on results from Lilly and Boehringer Ingelheim's extensive clinical development program for the alliance's insulin glargine product.
Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin. About 29 million Americans and an estimated 382 million people worldwide have type 1 or type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 85 to 95 percent of all diabetes cases.
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