Lilly Snags FDA Approval for Insulin Glargine Injection

Eli Lilly scored a win at the FDA last week, with the agency approving the company’s insulin Basaglar, to improve glycemic control in patients with Type 1 and 2 diabetes

Basaglar is the first insulin product approved through an abbreviated approval that relied in part on the FDA’s finding of safety and effectiveness for Sanofi’s Lantus (insulin glargine). The FDA granted tentative approval for Basaglar in August 2014.

The drugmaker provided Basaglar-specific data that included two clinical trials enrolling 534 and 744 patients with Type 1 and 2 diabetes mellitus, respectively.

Basaglar is indicated to improve glycemic control in adults with Type 2 diabetes and in combination with mealtime insulin in adults and pediatric patients with Type 1 diabetes.

About 21 million people have been diagnosed with diabetes, and the approval of Basaglar is expected to expand the availability of treatment options for doctors and patients, according to the FDA.