FDA Grants Tentative Approval for Basaglar (Insulin Glargine Injection)
Litigation delays final O.K.
The FDA has granted tentative approval for Basaglar (insulin glargine injection, Lilly/Boehringer Ingelheim), 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 not recommended for the treatment of diabetic ketoacidosis.
The basal insulin is intended to provide long-lasting blood sugar control in between meals and during the night.
Basaglar has the same amino acid sequence as the currently marketed insulin glargine product and was tentatively approved for use with the KwikPen, a pre-filled dosing device. Basaglar is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin glargine or one of its other ingredients.
With its tentative approval, the FDA has determined that Basaglar meets all of the regulatory requirements for approval, but the product is subject to an automatic stay of up to 30 months as a result of litigation filed by Sanofi, claiming patent infringement. Under the Drug Price Competition and Patent Term Restoration Act, the FDA cannot give final approval until the end of the 30-month period in mid 2016, unless the court finds in favor of Lilly earlier.
The FDA submission included results from pharmacokinetic and pharmacodynamic studies, as well as from phase III trials in subjects with type-1 and type-2 diabetes.
The trade name Basaglar was granted provisional approval by the FDA and will be used in the U.S. market once the product is made available to patients.
Approximately 29 million Americans have type-1 or type-2 diabetes. Type-2 diabetes is the most common form, accounting for an estimated 85% to 95% of all diabetes cases.
Source: Eli Lilly; August 18, 2014.