09 Jul 2013, BioSpectrum Bureau , BioSpectrum
Singapore: European Medicines Agency (EMA) has accepted Eli Lilly and Boehringer Ingelheim's marketing authorisation application (MAA) for LY2963016, an investigational basal (long-acting) insulin for the treatment of type 1 and type 2.
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 Dr Gwen Krivi,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," Dr Gwen Krivi added.