Eli Lilly new insulin to improve glycemic control in diabetics get positive opinion from EMA

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 in the European Union, and the medicine has been referenced to date as URLi or LY900014 in scientific disclosures.

"Today's CHMP opinion brings us another step closer to providing adults with diabetes in Europe with a new treatment option to help manage their blood glucose levels, especially their blood glucose levels following meals," said Deirdre Ibsen, global development leader for insulins, Lilly. "Maximizing the amount of time spent in the target blood glucose range is a constant balancing act and daily challenge. Many people with diabetes struggle to keep their blood glucose in the target range following meals and may benefit from a mealtime insulin with a fast onset of action."

The positive opinion was based on clinical pharmacological studies in type 1 and type 2 diabetes and studies from the PRONTO clinical program. PRONTO-T1D and PRONTO-T2D were designed as phase 3 treat-to-target trials in which each arm is treated to achieve the same level of glycemic control, allowing comparisons in other important treatment effects, such as rates of hypoglycemia, post-meal glucose control and glucose time in range. Both studies met the primary endpoint of non-inferior A1C reduction from baseline compared to Humalog at 26 weeks, when URLi and Humalog were dosed at mealtime. Further, URLi demonstrated superior reduction in blood glucose spikes at both one hour and two hours after a test meal compared to Humalog.

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 3 studies.

Data from a phase 1 clinical pharmacology study in people with type 1 diabetes also showed that URLi was absorbed significantly faster into the blood stream compared to Humalog, insulin aspart and fast-acting insulin aspart. The early blood glucose profile with the investigational insulin closely matched that of participants without diabetes.

"We developed URLi to provide a mealtime insulin option that more closely mirrors the way insulin works in people without diabetes," Ibsen said. "We look forward to bringing this new treatment option to those living with diabetes as soon as possible."

Lilly has submitted URLi for approval with regulatory authorities in the U.S. and Japan.

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