Lilly's, Boehringer Ingelheim's Basaglar For Diabetes Granted Tentative FDA Approval

Eli Lilly and Boehringer Ingelheim announced in a press release that the Food and Drug Administration (FDA) has granted Basaglar (insulin glargine injection) tentative approval. The drug for type 1 and 2 diabetes has met all regulatory requirements, however because Sanofi has filed patent infringement litigation, approval is delayed for up to 30 months. The drug will be approved after the 30 months, or before, if a court rules in favor of Lilly and Boehringer Ingelheim.

Enrique Conterno, president of Lilly Diabetes, said, "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, and Lilly and Boehringer Ingelheim are committed to addressing the needs of people living with diabetes and providing support beyond the medicine."

Basaglar

Basaglar improves glycemic control in adults with type 2 diabetes and in adults and pediatric patients with type 1 diabetes when combined with mealtime insulin. The FDA tentatively approved the drug for use with KwikPen, a pre-filled dosing device. The FDA granted provisional approval to the trade name Basaglar. In Europe, the drug is known as Abasria and is considered a biosimilar. However, Lilly and Boehringer Ingelheim are seeking a brand name for worldwide marketing.  

FDA Action

Lilly and Boehringer Ingelheim filed the New Drug Application (NDA) through the FDA's 505(b)(2) regulatory pathway. Drug sponsors may file in that program under three conditions: when the application is complete with safety and efficacy information; when safety and efficacy information is included from studies not conducted by the applicant; or when the proposed product is identical to an approved product.  

The FDA tentatively approved the drug in part, based on results from the Lilly and Boehringer Ingelheim Diabetes Alliance and its clinical development program. The two companies’ submission to the FDA included Phase III studies with type 1 and type 2 diabetes patients and pharmacokinetic/pharmacodynamics studies.

Sanofi’s Patent Infringement Litigation

Basaglar was granted tentative approval due to Sanofi’s patent infringement litigation. Sanofi is a French company that makes Lantus, a best-selling diabetes drug which brought in sales of $7.8 billion last year, according to the IndyStar. Sanofi sued Lilly and Boehringer in a Delaware federal court in July 2014.