Paul K Owens, VP of Global Brand Development, Insulins & Glucagon at Eli Lilly & Company Shares Insights from the US FDA Approval of Lyumjev

Shots:

Paul talked about the approval of the Lyumjev Injection for the improvement of glycemic control in children and adolescents with diabetes. He also shared various details about Lyumjev
Paul further discussed the study design and the key findings from the registrational PRONTO-Peds study
The interview also talks about Lilly’s Diabetes Solution Center which helps eligible people who need assistance to afford Lilly’s medicines, including Lyumjev

Smriti: Please shed some light on the details (MOA, formulations, etc.) of the Lyumjev Injection.

Paul K Owens: Lyumjev is a formulation of insulin lispro that helps manage blood glucose and, as a rapid-acting insulin, works to help control high blood glucose levels after meals in children and adults with diabetes similar to how natural insulin works after meals in people without diabetes.

Lyumjev was first approved by the U.S. Food and Drug Administration (FDA) in June 2020 as a rapid-acting insulin to improve glycemic control in adults with type 1 and type 2 diabetes. In August 2021, the FDA approved an expanded label for Lyumjev® (insulin lispro-aabc injection) 100 units/mL to include administration via continuous subcutaneous insulin infusion (CSII) with an insulin pump. On October 14, 2022, the FDA approved Lyumjev® (insulin lispro-aabc injection), a rapid-acting mealtime insulin, for the treatment of children with diabetes.

Smriti: Brief us about the study design of the P-III (PRONTO-Peds) clinical trial evaluating the Lyumjev Injection.

Paul K Owens: PRONTO-Peds was a phase 3, randomized, treat-to-target study that evaluated the efficacy and safety of Lyumjev versus Humalog (insulin lispro injection) 100 units/mL in 716 children and adolescents with type 1 diabetes. Following a 4-week lead-in period, patients were randomized to either blinded Lyumjev (n=280) or Humalog (n=298), to be given at mealtime (0 to 2 minutes prior to the meal) or open-label Lyumjev (n=138) given up to 20 minutes after the start of the meal. The primary objective was noninferiority (noninferiority margin [NIM]=0.4% for A1C) of Lyumjev to Humalog at mealtime on change in A1C from baseline to week 26. Key multiplicity-controlled secondary objectives included non-inferiority of post-meal Lyumjev to Humalog at mealtime on change in A1C from baseline and superiority of Lyumjev to Humalog at mealtime on change in A1C from baseline.

Smriti: What were the key findings obtained from the (PRONTO-Peds) study evaluating the Lyumjev Injection in children and adolescents with diabetes?

Paul K Owens: The study showed that Lyumjev demonstrated noninferior A1C control from baseline to week 26 with a similar safety profile. It also showed that Lyumjev can be dosed up to 20 minutes after the start of a meal.

Smriti: What makes Lyumjev Injection a better option than the conventional treatment options available for the treatment of diabetes in children and adolescents?

Paul K Owens: Lyumjev (insulin lispro-aabc) injection is an important new treatment option for children with diabetes. Diabetes management is difficult at any age, but it can be particularly challenging for children. About 283,000 Americans 20 or younger are estimated to have diagnosed diabetes. And diabetes prevalence continues to rise in children. A study from the National Institute of Diabetes and Digestive and Kidney Disease reported that the prevalence for type 1 grew by 45% from 2001 to 2017 in children up to age 19.

Smriti: In which geographical locations does Eli Lilly plans to commercialize Lyumjev Injection?

Paul K Owens: Lyumjev is approved for use by adults via multiple daily injections and via insulin pumps in the U.S. and in several global markets, including Japan and the European Union. Lyumjev is now approved for the treatment of children in the U.S., Japan and Saudi Arabia. Additionally, the European Medicines Agency’s for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Lyumjev for the treatment of children on October 13. This opinion is an important regulatory step toward European approval of Lyumjev for children.

Smriti: Tell our readers some more about Lilly’s Diabetes Solution Center service. How does this service help patients easily access Lyumjev Injection?

Paul K Owens: Lyumjev is available on most plans where Humalog is available. For those who need help affording their Lilly insulin, including Lyumjev, Lilly offers several options at the Lilly Diabetes Solution Center at (833) 808-1234 and www.insulinaffordability.com. People who have commercial insurance can visit www.Lyumjev.com to access the Lyumjev Savings Card. Lyumjev is also included in the Lilly Insulin Value Program for people with commercial insurance or no insurance at all, as well as in the Seniors Savings Model for people in the Medicare Part D program—allowing them to fill their monthly prescription of Lyumjev for $35. Other restrictions may apply.

Anyone can call the Lilly Diabetes Solution Center at (833) 808-1234 to speak with a live representative. Patients and healthcare providers with questions about Lyumjev can also visit www.Lyumjev.com.

Image source: Canva

About the Author:

Paul K. Owens is the Global Brand Development Leader, Insulins, Glucagon & Devices at Eli Lilly & Company. Paul joined Eli Lilly & Co in 2003. In his current role within Lilly Diabetes, he has primary responsibilities for the global development of new insulin assets, in addition to lifecycle management for all Lilly insulin and Lilly glucagon brands. Paul received his BSc degree in Analytical Chemistry and his Ph.D. degree in Pharmaceutical Chemistry from the School of Pharmacy at Bradford University, United Kingdom. He received his Master of Business Administration from the University of Chicago Booth School of Business in 2014 with a concentration in Entrepreneurship. He is a Fellow of the Royal Society of Chemistry in London and has authored over 30 research publications.