EMA accepts Boehringer, Lilly diabetes drug for review

The European Medicines Agency (EMA) has accepted Boehringer Ingelheim and Eli Lilly & Company’s marketing authorization application for review of their type 1 and type 2 diabetes drug, LY2963016.

LY2963016 is an investigational basal (long-acting) insulin for the treatment of type 1 and type 2 diabetes. It is a new insulin glargine product and has been filed through the EMA’s biosimilar pathway.

Phase 3 clinical trials of LY2963016 in patients with type 1 and type 2 diabetes have been conducted and results submitted, using currently marketed insulin glargine as the active comparator.

“Long-acting insulin is a mainstay treatment for many people with diabetes, and we anticipate that insulin glargine will continue to be widely used for many years to come. We are pleased that the EMA’s acceptance of our application brings us closer to offering a new insulin glargine product to clinicians and their patients, coupled with the expertise they expect from Lilly and Boehringer Ingelheim.”

Gwen Krivi, Ph.D., vice president, Lilly Diabetes product development.

An estimated 371 million people worldwide have type 1 and type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90% of all diabetes cases.

Boehringer Ingelheim and Eli Lilly and Company began their diabetes alliance in January 2011.



Related news:

Eli Lilly and Company and Boehringer Ingelheim announce regulatory submission for new insulin glargine biosimilar product (Wall Street Journal)

Reference links:

Lilly press release

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