Basaglar Approved for Type 1, 2 Diabetes Mellitus

FDA Issues Complete Response Letter for Diabetes Drug
FDA Issues Complete Response Letter for Diabetes Drug

The Food and Drug Administration (FDA) has approved Basaglar (insulin glargine; Eli Lilly and Boehringer Ingelheim) injection to improve glycemic control in pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. 

Basaglar, a long-acting human insulin analog, has an identical amino acid sequence to Lantus (insulin glargine; Sanofi) injection. It is the first insulin product to receive approval through an abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act. 

RELATED: New Basal Insulin Granted Tentative FDA Approval

The FDA's approval was partly based on a clinical development program that included data from pharmacokinetic and pharmacodynamic studies, as well as Phase 3 studies in patients with type 1 and type 2 diabetes comparing Basaglar to Lantus. Basaglar was granted tentative approval from the FDA in August 2014.

The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin and its analog lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis. 

Basaglar will be available as a 100 units/mL (U-100) strength and is delivered via the prefilled 3mL Basaglar KwikPen. It will be available starting December 15, 2016.

For more information call (800) 545-5979 or visit LillyDiabetes.com.
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