FDA approves Basaglar as long-acting insulin

The FDA recently approved Basaglar, a long-acting human insulin analog for the improvement of glycemic control in adults and pediatric patients with type 1 diabetes and adults with type 2 diabetes.

Basaglar (insulin glargine injection, Eli Lilly and Company) was approved through an abbreviated pathway under the Federal Food, Drug and Cosmetic Act. The safety and efficacy of Basaglar is comparable to Lantus (insulin glargine, Sanofi).

Dosing should be individualized to each patient’s needs and is administered subcutaneously once daily at the same time every day. It should not be used during hypoglycemic episodes.

Basaglar may cause low blood glucose, so health care providers should closely monitor patients with changes to insulin dosage, co-administration of other glucose-lowering medications, meal pattern, physical activity and those patients with renal impairment, hepatic impairment or hypoglycemia unawareness.

Common adverse side effects include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, itching, rash, edema and weight gain.

“Long-acting insulin products like insulin glargine play an important role in the treatment of types 1 and 2 diabetes mellitus, and today’s approval is expected to expand the availability of treatment options for health care professionals and patients,” Jean-Marc Guettier, MD, director of the division of metabolism and endocrinology products in the FDA’s Center for Drug Evaluation and Research, said in the release.