FDA Approves Long-Acting Basaglar to Treat Diabetes

The FDA has approved insulin glargine injection, a long-acting human insulin analog to improve glycemic control among adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes.

The FDA has approved insulin glargine injection (Basaglar), a long-acting human insulin analog to improve glycemic control among adult and pediatric patients with type 1 diabetes and among adults with type 2 diabetes.

Eli Lilly and Company demonstrated that Basaglar was safe, effective, and sufficiently similar to Lantus. Two clinical trials of Basaglar involved 1278 patients with type 1 or type 2 diabetes.

“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,” said Jean-Marc Guettier, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, in a press release.

Basaglar should be administered to patients once per day at the same time each day. Dosing should depend on the individual’s needs.

Some life-threatening allergic reactions have been noted in association with Basaglar, including anaphylaxis. Generalized skin reactions have also been observed in patients.

However, the most common adverse effects linked to Basaglar include itching at the injection site, rash, weight gain, and edema.