Eli Lilly and Company and Boehringer Ingelheim announce regulatory submission for new insulin product
European Medicines Agency accepted companies' marketing authorisation application
Eli Lilly and Company (LLY) and Boehringer Ingelheim announced that the companies' marketing authorisation application (MAA) for LY2963016, an investigational basal (long-acting) insulin for the treatment of type 1 and type 2 diabetes, has been accepted for review by the European Medicines Agency (EMA). LY2963016 is a new insulin glargine product and has been filed through the EMA's biosimilar pathway.
Lilly and Boehringer Ingelheim have studied LY2963016 in a comprehensive clinical development program in order to meet the highest standards of safety, efficacy and quality. In addition to pharmacokinetic and pharmacodynamic studies, Phase III studies 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," said Gwen Krivi, Ph.D., vice president, Lilly Diabetes product development. "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."
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