CHMP recommends Lilly's new fast-acting mealtime insulin (Liumjev) to improve glycemic control in adults with diabetes.

Eli Lilly and Company announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Lilly's new mealtime insulin for the treatment of adults with diabetes as part of a multiple daily injection regimen or delivered by an insulin pump. This novel, fast-acting formulation of insulin lispro is being evaluated for use in adults with type 1 and type 2 diabetes to reduce blood glucose. This is the first regulatory step toward approval for this new insulin in Europe. The CHMP opinion is now referred for final action to the European Commission, which grants approval in the European Union. Lilly plans to market the medicine under the trade name Liumjev ( formerly LY 900014 and URLi) in the European Union, and the medicine has been referenced to date as URLi or LY 900014 in scientific disclosures. Lilly has submitted URLi for approval with regulatory authorities in the U.S. and Japan. The positive opinion was based on clinical pharmacological studies in type 1 and type 2 diabetes and studies from the PRONTO clinical program . Overall, URLi showed no significant difference in severe, nocturnal or overall hypoglycemia rates in study participants compared to Humalog, and the two insulins had similar safety and tolerability profiles across Phase III studies.