Tentative FDA approval for Lilly and Boehringer Ingelheim's Basaglar

19 August 2014

The US Food and Drug Administration yesterday granted tentative approval for Basaglar (insulin glargine injection), 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, which is not recommended for the treatment of diabetic ketoacidosis, is US drug major Eli Lilly (NYSE: LLY) and German family-owned pharma company Boehringer Ingelheim's basal insulin, which 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 – French drug major Sanofi’s Lantus - and was tentatively approved for use with 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.

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