The U.S. Food and Drug Administration has granted tentative approval for an insulin drug co-developed by Eli Lilly and Co. that helps control blood-sugar levels in diabetes patients, according to the Indianapolis-based drugmaker.
Called Basaglar, the drug is approved for adults with type 2 diabetes and in combination with mealtime insulin for adults and children with type 1 diabetes. It’s intended to control blood sugar between meals and during the night.
Lilly co-developed the drug with Germany-based pharmaceutical firm Boehringer Ingelheim.
With the tentative approval, the FDA has found that Basaglar meets all of the regulatory requirements for full approval. However, due to claim of patent infringement filed by drugmaker Sanofi, the FDA cannot give final approval of Basaglar until mid-2016, unless courts find in favor of Lilly earlier.
About 29 million Americans and 382 million people worldwide have type 1 or type 2 diabetes. Lilly has been at the front of diabetes care since 1923, when it introduced the world’s first commercial insulin, a hormone that regulates the amount of glucose in the blood.