Eli Lilly and Boehringer Ingelheim's application for review of MAA for new insulin glargine biosimilar product accepted by European Medicines Agency.
Pharmaceutical products company Eli Lilly and Company (NYSE:LLY) and pharmaceutical company Boehringer Ingelheim announced on Monday that the European Medicines Agency (EMA) has accepted and will review their marketing authorisation application (MAA) for LY2963016, an investigational basal (long-acting) insulin for the treatment of type 1 and type 2 diabetes,
LY2963016 is a new insulin glargine product and has been filed through the EMA's biosimilar pathway.
According to the companies, they have studied LY2963016 in a comprehensive clinical development programme 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.
Boehringer Ingelheim and Eli Lilly and Company had announced an alliance in January 2011 in the field of diabetes that centres on three compounds representing several of the largest treatment classes.
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|Publication:||Worldwide Computer Products News|
|Date:||Jul 9, 2013|
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