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Lyumjev ® ▼ (insulin lispro)
This information is intended for UK registered healthcare professionals only in response to your search for information. For current information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).
Is Lyumjev® (insulin lispro) indicated for use in pediatrics?
Lyumjev is authorised for the treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
European Approval
On October 13, 2022, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending an extension to the existing indication to include treatment of adolescents and children of Lyumjev (insulin lispro).1
On November 18, 2022, Lyumjev was approved by the EU Commission for the treatment of diabetes mellitus in adults, adolescents, and children aged 1 year and above.2
On January 26, 2023, the change was approved by the Medicines and Healthcare Regulatory Agency (MHRA), extending the existing indications to include adolescents and children aged 1 year and above.3
The indication extension is based on the release of the clinical data on the PRONTO-Peds phase 3, prospective, randomized, outpatient, multinational, multicenter, parallel, active-controlled study conducted in children and adolescent patients aged at least 1 to less than 18 years with type 1 diabetes who were using a multiple-daily-injection regimen.4,5
PRONTO-Peds: Phase 3 clinical study
PRONTO-Peds was a 3-treatment group design study that included
- 2 treatment groups that were administered Lyumjev® (insulin lispro) 100 units/mL or Humalog® (insulin lispro) 100 units/mL 0 to 2 minutes prior to each meal in a double-blind manner, and
- a third open-label treatment group that was administered Lyumjev up to 20 minutes after the start of a meal.4
Patients included in this study were treated in combination with basal insulin including
- insulin glargine 100 units/mL daily or twice daily
- insulin detemir 100 units/mL daily or twice daily, or
- insulin degludec 100 units/mL daily.4
References
1Committee for Medicinal Products for Human Use (CHMP); European Medicines Agency. Opinion: Lyumjev. EMA/CHMP/805193/2022. October 13, 2022. Accessed October 17, 2022. https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-lyumjev-ii-14_en.pdf
2European Commission decision for Lyumjev: http://ec.europa.eu/health/documents/community-register/html/h1422.htm
3Trulicity [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
4Wadwa RP, Laffel LM, Franco DR, et al. Efficacy and safety of ultra-rapid lispro versus lispro in children and adolescents with type 1 diabetes: the PRONTO-Peds trial. Diabetes Obes Metab. Published online August 24, 2022. https://doi.org/10.1111/dom.14849
5US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Drug Approval and Databases (Drugs@FDA): FDA-Approved Drugs. LYUMJEV Biologic License Application (BLA): 761109/S-004. Updated October 14, 2022. Accessed October 17, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761109Orig1s004ltr.pdf
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Date of Last Review: 17 October 2022