Lilly quick acting insulin is recommended and approved by CHMP

Eli Lilly recently announced that the European Drug Administration (EMA) Committee on human pharmaceutical products (CHMP) has issued a positive review, suggesting approval of the company's new meal insulin product as part of the daily multiple injection program or as administered by an insulin pump for the treatment of adults with diabetes This is a new and quick acting preparation of insulin lispro It is currently being used to evaluate the adult patients with type 1 diabetes and type 2 diabetes, so as to better manage the blood glucose level The CHMP review is the first regulatory step for the new insulin product to be approved in the EU The CHMP's comments will now be submitted to the European Commission (EC), which is expected to make a final review decision in the coming months If approved by EC, Lilly plans to sell the new insulin product under the brand name of liumjev In the European Union, the drug is known in scientific disclosure as urli or ly900014 In addition to the European Union, Lilly has also applied to regulators in the United States and Japan for the listing of urli The positive opinion of CHMP is based on the clinical pharmacology research carried out in patients with type 1 and type 2 diabetes and the research of Pronto clinical project In this project, pronto-t1d and pronto-t2d are both phase III trials for treatment up to standard They are carried out in adult patients with type 1 diabetes and type 2 diabetes respectively The efficacy and safety of urli and Humalog combined with insulin glargine or insulin degluc are compared In both studies, patients in each group were treated until they reached the same level of glycemic control to allow comparison in other important therapeutic effects, such as hypoglycemia rate, postprandial glycemic control, and glycemic time range The results showed that both studies reached the primary end point: at meal time, at 26 weeks of treatment, urli was not inferior to Humalog in terms of A1C relative baseline reduction In addition, in the trial meal test, compared with Humalog, urli significantly reduced the peak blood glucose at 1 hour (- 27.9mg / dl [T1D], - 11.8mg / dl [T2D]) and 2 hours (- 31.2mg / dl [T1D], - 17.4mg / dl [T2D]) after meal In general, there was no significant difference in serious low, nocturnal, and overall hypoglycemia rates between urli and Humalog, and insulin had similar safety and tolerance Data from a phase I clinical pharmacology study in patients with type 1 diabetes also support the role of urli in postprandial glycemic control The results showed that the absorption rate of urli into the blood was significantly faster than that of Humalog, insulin aspart and insulin aspart Test meal test showed that compared with the tested insulin, urli also showed a lower peak blood glucose, which was significantly different from Humalog and insulin aspart In addition, the early blood glucose curve of urli was very consistent with that of subjects without diabetes.