Lilly applies for listing of its fast-acting insulin Lyumjev

Started reimbursement application process immediately after receiving approval in December… effective in adults with Type 1 and Type 2 diabetes

Efficacy confirmed trough PRONTO clinical trial.. demonstrated non-inferiority in comparison to Humalog

The reimbursement benefit listing process for Lilly’s fast-acting insulin ‘Lyumjev’ will begin.

 

According to industry sources, Lilly Korea had recently applied for the reimbursement of Lyumjev (insulin lispro).

 

The drug, which has been approved in Korea on the 28th of last month, is attempting quicker market entry using the Drug Approval – Benefit Evaluation Linkage System.

 

Lyumjev is a mealtime insulin that contains the fast-acting active ingredient, ‘insulin lispro’ which helps patients with Type 1 and Type 2 diabetes control their high blood sugar levels after meals or maintain their blood sugar in the target range.

 

The domestic approval of Lyumjev was based on the results of the PRONTO clinical trial program that was conducted on adult patients with Type 1 and Type 2 diabetes.

 

The PRONTO-T1D and PRONTO-T2D trials evaluated the safety and efficacy of Lyumjev compared to Humalog in people with type 1 and type 2 diabetes, respectively.

 

The studies were designed as treat-to-target trials in which each arm was treated to achieve the same level of blood glucose control and evaluated for other important treatment effects, such as rates of hypoglycemia and post-meal glucose control, as well as maintenance of appropriate blood sugar levels.

 

Results from both studies showed that Lyumjev was found to be non-inferior to Lilly’s existing fast-acting insulin ‘Humalog (insulin lispro) with regard to HbA1c reduction from baseline to week 26 (primary endpoint) when administered after meals.

 

Also, Lyumjev demonstrated a superior reduction in blood glucose spikes at both one hour and two hours after a test meal compared to Humalog.

 

Results of Phase 1 clinical trial on Type 1 diabetes patients had also shown that Lyumjev is absorbed faster than ‘Humalog,’ ‘insulin aspart’ and ‘fast-acting insulin aspart.’ Also, blood glucose excursions over the first 3 hours after administration of Lyumjev were comparable to those in participants without diabetes.