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FDA Approves Basaglar for the Treatment of Diabetes

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FDA Approves Basaglar for the Treatment of Diabetes
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The U.S. Food and Drug Administration (FDA) recently approved a version of insulin glargine injection (Basaglar, Eli Lilly and Company) for the treatment of diabetes. The drug was approved for the improvement of glycemia control in pediatric and adult patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

In the U.S., almost 21 million people have been diagnosed with diabetes, according to the Centers for Disease Control and Prevention. Diabetes is known to increase the risk of severe health problems, such as kidney and nerve damage, heart disease and blindness. Diabetes refers to a group of diseases that affect how the body uses glucose, a vital compound for the body because it is an important source of energy for the cells that constitute the muscles and tissues, and is also the brain’s main source of fuel. Insulin helps control blood sugar levels and convert sugar, starches and other foods into energy.

“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, MD, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research in a recent news release.

Basaglar is the first insulin product approved via an abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act. The 505(b)(2) application submitted for Basaglar partly relied on the FDA’s finding of effectiveness and safety for Lantus (insulin glargine injection). Basaglar was found to be satisfactorily comparable to Lantus. Data from two clinical trials on Basaglar that included 534 patients with type 1 and 744 patients with type 2 diabetes established the product’s efficacy and safety for its approved indications.

Basaglar is administered once daily subcutaneously with the manufacturer’s KwikPen injector. The drug can be administered at any time of day as long it is at the same time every day. Clinicians should dose the insulin analogue on the basis of the individual patients’ needs.

The new diabetes therapy may induce hypoglycemia, a condition that can become life-threatening, so patients should be closely monitored for their glycemic levels. Hypoglycemia, allergic reactions, injection site reactions, pitting at the injection site (lipodystrophy), edema, weight gain, itching and rash were the most common adverse events linked to Basaglar in the clinical trials. The FDA noted that any insulin-based treatment comes with the risk for anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock.

Basaglar is considered by the FDA to be a follow-on product; it is not approved as a biosimilar drug. No insulin glargine drugs are presently certified under the Public Health Service Act, meaning that there is no “reference product” to consider possible biosimilar products.

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