(Adds details on the drug)
Aug 18 (Reuters) - The U.S. Food and Drug Administration granted tentative approval for Eli Lilly and Co and Boehringer Ingelheim’s insulin injection that helps control blood sugar levels in diabetes patients, Lilly said in a statement.
The drug, Basaglar, is intended to provide long-lasting blood sugar control in between meals and during the night. It is approved for adults with type 2 diabetes and in combination with mealtime insulin in adults and children with type 1 diabetes.
Although the drug meets all regulatory requirements for approval, it is subject to an automatic stay order of up to 30 months because of litigation filed by Sanofi SA.
Sanofi, whose top-selling Lantus helps diabetics control blood sugar levels, has brought a lawsuit accusing Lilly of infringing seven patents related to insulin and devices used to deliver it.
FDA cannot give final approval until the end of the 30-month period in mid-2016, unless a court finds in favor of Lilly earlier.
About 29 million Americans and an estimated 382 million people worldwide have type 1 or type 2 diabetes, a chronic condition that occurs when the body does not properly produce or use the hormone insulin. (Reporting by Susan Kelly in Chicago and Anjali Rao Koppala in Bangalore; Editing by Lisa Shumaker)