CHMP Recommends Approval of Lilly's Novel Fast-Acting Mealtime Insulin URLi (Lyumjev) for Improved Postprandial Glucose Control in Adults with Diabetes

Feb 08, 2020 16:06 CST Updated 16:06

Eli Lilly

Global Pharmaceutical R&D and Production Company

Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.

February 08, 2020 / BIOON -- Eli Lilly recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending approval of the company’s new mealtime insulin product as part of a multiple daily injection regimen or administered via an insulin pump for the treatment of adult patients with diabetes. This novel, rapid-acting formulation of insulin lispro is currently being evaluated for use in adult patients with type 1 and type 2 diabetes to better manage blood glucose levels.

CHMP review is the first regulatory step for this novel insulin product to gain approval in the European Union. The CHMP’s opinion will now be submitted to the European Commission (EC) for review, which is expected to make a final decision within the coming months. If approved by the EC, Eli Lilly plans to market this novel insulin product under the brand name Liumjev. In the European Union, the drug is referred to as URLi or LY900014 in scientific disclosures. In addition to the European Union, Eli Lilly has also submitted marketing applications for URLi to regulatory authorities in the United States and Japan.

The CHMP’s positive opinion is based on clinical pharmacology studies conducted in patients with type 1 and type 2 diabetes, as well as findings from the PRONTO clinical program. Within this program, PRONTO-T1D and PRONTO-T2D were both treat-to-target Phase III trials conducted in adult patients with type 1 and type 2 diabetes, respectively. These trials compared the efficacy and safety of URLi versus Humalog (insulin lispro), each administered in combination with either insulin glargine or insulin degludec. In both studies, patients in each group received treatment until they achieved comparable levels of glycemic control, thereby enabling comparisons of other key therapeutic outcomes, such as hypoglycemia rates, postprandial glucose control, and time in range.

The results showed that both studies met their primary endpoints: at Week 26 of treatment with mealtime dosing, URLi was non-inferior to Humalog in terms of reduction in A1C from baseline. Furthermore, in standardized meal tests, URLi significantly reduced postprandial glucose peaks at 1 hour (-27.9 mg/dL [T1D], -11.8 mg/dL [T2D]) and 2 hours (-31.2 mg/dL [T1D], -17.4 mg/dL [T2D]) compared with Humalog. Overall, there were no significant differences between URLi and Humalog in the rates of severe hypoglycemia, nocturnal hypoglycemia, or overall hypoglycemia, and the two insulins demonstrated similar safety and tolerability profiles.

Data from a Phase I clinical pharmacology study in patients with type 1 diabetes also demonstrated the efficacy of URLi in controlling postprandial blood glucose. The results showed that URLi was absorbed into the bloodstream significantly faster than Humalog, insulin aspart, and faster-acting insulin aspart. Meal challenge tests revealed that URLi produced lower peak blood glucose levels compared to the tested insulins, with statistically significant differences observed versus Humalog and insulin aspart. Furthermore, the early blood glucose profile of URLi closely matched that of non-diabetic subjects.

Deirdre Ibsen, Global Head of Insulin Development at Eli Lilly, stated: “Today’s CHMP opinion brings us closer to providing a new treatment option for people with diabetes in Europe, helping them manage their blood glucose levels, particularly postprandial glucose. Maximizing the time patients spend within their target glucose range is a critical consideration and a daily challenge. Many individuals with diabetes struggle to keep their blood glucose within the target range after meals. URLi, which we have developed, is a new mealtime insulin therapy that more closely mimics how insulin functions in individuals without diabetes. We look forward to making this new treatment option available to people with diabetes as soon as possible.”(BioValley Bioon.com)

Original Source: CHMP Recommends Approval of Lilly's New Fast-Acting Mealtime Insulin to Improve Glycemic Control in Adults with Diabetes