Lilly and Boehringer Ingelheim’s Basaglar granted tentative approval
INDIANAPOLIS and RIDGEFIELD, Conn. — The Food and Drug Administration has granted tentative approval for Basaglar (insulin glargine injection), which is used 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 Co. and Boehringer Ingelheim's basal insulin, which provides bloog sugar control in between meals and at night. The drug is not recommended for the treatment of diabetic ketoacidosis, the companies said.
"The tentative approval for Basaglar is another step toward providing an important option for people with diabetes in the United States who need basal insulin treatment," said Enrique Conterno, president of Lilly Diabetes. "We believe insulin glargine will continue to be used widely for many years, and Lilly and Boehringer Ingelheim are committed to addressing the needs of people living with diabetes and providing support beyond the medicine."
While the FDA has determined that Basaglar meets the regulatory requirments for approval, it is subject to an automatic stay of up to 30 months due to litigation filed by Sanofi, which claimed patent infringement. Due to the Drug Price Competition and Patent Term Restoration Act, the agency cannot grant final approval until the end of the 30-month period in mid-2016, unless the court finds in favor of Lilly before such time.