Lilly wins tentative approval for diabetes drug

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.
 

Please enable JavaScript to view this content.

Story Continues Below

Editor's note: IBJ is now using a new comment system. Your Disqus account will no longer work on the IBJ site. Instead, you can leave a comment on stories by signing in to your IBJ account. If you have not registered, please sign up for a free account now. Past comments are not currently showing up on stories, but they will be added in the coming weeks. Please note our updated comment policy that will govern how comments are moderated.