Lilly and Boehringer Ingelheim's basal insulin MAA accepted by EMA

8 July 2013

US drug major Eli Lilly (NYSE: LLY) and family-owned German pharma firm Boehringer Ingelheim today announced that their marketing authorization application (MAA) for an investigational basal insulin for the treatment of type 1 and type 2 diabetes has been accepted for review by the European Medicines Agency.

LY2963016 is a new insulin glargine product and has been filed through the EMA's biosimilar pathway. If approved, it will compete with blockbuster products such as Sanofi’s Lantus (insulin glargine), whose patent expires in 2014, and Novo Nordisk’s Victoza (liraglutide [rDNA origin] injection).

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.

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