FDA Grants Basaglar Tentative Approval for Diabetes

The FDA today granted tentative approval of Basaglar (insulin glargine injection) for treatment of diabetes, according to a press release.

The drug is indicated for improvement of glycemic control in adults with type 2 diabetes, and in combination with mealtime insulin in adults and children with type 1 diabetes. Basaglar, however, is not recommended for treatment of diabetic ketoacidosis. It is also contraindicated for use during episodes of hypoglycemia and in patients with hypersensitivity to insulin glargine.

Basaglar was tentatively approved for use with the prefilled dosing device KwikPen and has the same amino acid sequence as the currently available insulin glargine product.

Tentative approval indicates that the FDA determined that Basaglar meets regulatory requirements for approval, but the product is subject to an automatic stay of up to 30 months due to litigation claiming patent infringement filed by Sanofi. Consequently, the FDA cannot grant final approval until the conclusion of the 30-month period unless the court makes its decision earlier, according to the release.