Lilly, Boehringer Ingelheim Get Tentative FDA OK For Basaglar
Eli Lilly together with its partner Boehringer Ingelheim announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval to Basaglar (insulin glargine injection) indicated for the improvement of glycemic control in adult patients with Type 2 diabetes.
Basaglar is basal insulin intended to provide blood sugar control for an extended period of time for diabetic patients in between meals and during nighttime. The drug is also indicated in combination with mealtime insulin in patients with type 1 diabetes. Basaglar is considered a biosimilar of Sanofi’s Lantus in the EU, as it contains the same amino acid sequence of the currently marketed insulin glargine product. The drug is not considered a biosimilar in the U.S. Due to a litigation filed by Sanofi earlier this year, Basaglar remains under an automatic stay of up to 30 months. The FDA may give final approval at the end of the 30-month period or earlier if the court rules in favor of Eli Lilly.
The company said that with its tentative approval, the federal agency has determined that Basaglar meets all of its regulatory requirements. “The tentative approval for Basaglar is another step toward providing an important option for people with diabetes in the U.S. who need basal insulin treatment. We believe insulin glargine will continue to be used widely for many years,” said Enrique Conterno, president of Lilly Diabetes.
Dr. Christophe Arbet-Engels, VP of metabolic-clinical development and medical affairs at Boehringer Ingelheim, said, “We are confident that Basaglar, upon final approval, will become a valuable treatment choice for people who need a basal insulin to manage their type 1 or type 2 diabetes.”
The tentative approval was supported by positive results from pharmacokinetic and pharmacodynamics studies as well as Phase III studies in patients with type 1 and type 2 diabetes conducted by Eli Lilly and Boehringer Ingelheim.