Basaglar Receives Tentative FDA Approval for Diabetes Treatment

A new drug was recently given tentative approval by the US Food and Drug Administration to help patients with both type 1 and type 2 diabetes.

According to a press release from Eli Lilly & Company, Basaglar, an insulin glargine injection, has shown indications of helping adults with type 2 diabetes and pediatric type 1 diabetes patients with glycemic control when taken with insulin during meals.

With the same amino acid sequence as other insulin glargine products on the market, Basaglar was given the tentative approval to be used with KwikPen.

“Basaglar is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin glargine or one of its other ingredients,” the statement noted.

Lilly Diabetes President, Enrique Conterno, said the approval from the FDA meant good news for patients living with diabetes. “We believe insulin glargine will continue to be widely used for many years and Lilly and Boehringer Ingelheim are committed to addressing the needs of people living with diabetes and providing support beyond the medicine.”

The approval came based in part on the prior success the company has had with insulin glargine products and the fact that it is a biosimilar in places like Europe. The Committee for Medicinal Products for Human Use, a division of the European Medicines Agency, gave Basaglar a “positive recommendation,” according to the release.

“Because of the combined diabetes, development and commercialization experience of Lilly and Boehringer Ingelheim, we are confident that Basaglar, upon final approval will become a valuable treatment choice for people who need a basal insulin to manage their type 1 or type 2 diabetes,” said Christophe Arbet-Engels, MD, PhD, vice president of metabolic-clinical development and medical affairs for Boehringer-Ingelheim.

With the tentative approval the drug must go through a stay of up to 30 months as the result of patent infringement legal action by Sanofi. Barring an earlier court decision the final approval likely will not come for Basaglar until sometime in the middle of 2016.

The statement from the company said the drug is not being recommended for treatment of diabetic ketoacidosis.