In an interview with PharmaShots, Kevin Cammack, Head of Connected Care, Eli Lilly, and Mark Warren, MD, Director of Endocrine Clinical Trials and Laboratory Services, Physicians East share their views on the US FDA’s approval of rapid-acting insulin, Lyumjev (insulin lispro-aabc injection) 100 units/mL indicated to improve glycemic control in adults with type 1 and type 2 diabetes.

Shots:

• The US FDA has expanded the approval for Lyumjev (insulin lispro-aabc injection) U-100 () to include administration via CSII with an insulin pump to improve glycemic control in adults with T1D & T2D
• The approval was based on P-III PRONTO-PUMP-2 study that confirmed the efficacy & safety of Lyumjev when used in insulin pumps in adults with T1D. The study met the 1EPs of noninferior A1C reduction from baseline to week 16 compared to Humalog (insulin lispro injection) 100 units/mL
• Lyumjev is a novel formulation of insulin lispro that helps manage blood glucose and, as a rapid-acting insulin, works to control high blood glucose levels after meals in adults with diabetes like how natural insulin works after meals in people without diabetes. It is also available as 200 units/mL but this strength is not approved for use in insulin pumps

Response by Kevin Cammack, Head of Connected Care, Eli Lilly

Tuba: What does this approval mean for patients suffering from type 1 and type 2 diabetes?

Kevin: Many people with diabetes struggle to keep their blood glucose levels in the target range. That's why we developed Lyumjev— which was first approved by the FDA in June 2020 as rapid-acting insulin to improve glycemic control in adults with type 1 and type 2 diabetes. Based on the time action profile, we’re excited to now provide an option to support people with diabetes who use insulin pumps and are considering transitioning to an insulin-like Lyumjev to help manage their blood sugar levels.

Source: Lyumjev

Tuba: Do you have any plans to bring this insulin therapy for children and gestational diabetic patients?

Kevin: Based on the time action profile, Lyumjev may provide important benefits to many people who use insulin to manage their diabetes. We will continue to study Lyumjev in different patient populations, with different technologies, and indifferent delivery systems.

Tuba: List Eli Lilly’s insulin value programs conducted by the company for diabetic patients.

Kevin: Lilly offers several solutions to help eligible people who need assistance accessing their Lilly insulin, including Lyumjev, 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.

Tuba: Can we expect more insulin products from Eli Lilly in the near future?

Kevin: At Lilly, we are always looking to bring more options to meet the diverse needs of the millions of people living with diabetes, including new medicines, technologies, and different delivery systems within the insulin space. Addressing the impact of diabetes has been at the heart of our purpose for a century—and we remain strong in our commitment to deliver breakthrough outcomes through innovative solutions.  

Response by Mark Warren, MD, Director of Endocrine Clinical Trials and Laboratory Services, Physicians East

Tuba: Describe the characteristics of Lyumjev.

Mark: Lyumjev is a novel formulation of insulin lispro that helps manage blood glucose and, as rapid-acting insulin, works to control high blood glucose levels after meals in adults with diabetes similar to how natural insulin works after meals in people without diabetes. Controlling blood sugar after meals is difficult and frustrating for people with diabetes. Lyumjev shows clinically significant improvements in post-meal blood sugar control.

Tuba: Discuss the clinical study supporting the approval of Lyumjev for use in insulin pumps.

Mark: The updated label is based on the FDA’s review of data from PRONTO-PUMP-2, a phase 3, randomized, prospective, double-blind, active-controlled treat-to-target study in which Lyumjev demonstrated non-inferior A1C reduction from baseline to week 16 compared to Humalog (insulin lispro injection) 100 units/mL when used in insulin pump therapy in adults with type 1 diabetes.  

Tuba: As Lyumjev is a novel formulation of insulin lispro, how does it differ from Humalog?  

Mark: In Phase 1 studies, Lyumjev had a faster onset of action than Humalog. In the Phase 3 trials, PRONTO-T1D, PRONTO-T2D, and PRONTO-PUMP-2, Lyumjev provided noninferior A1C reductions compared to Humalog in people with type 1 and type 2 diabetes. Lyumjev demonstrated a superior reduction in blood glucose spikes at both one hour and two hours after a test meal compared to Humalog. Lyumjev also provided superior postprandial glucose-lowering at one and two hours after a test meal, which was significant compared to Humalog. Better control of post-meal blood sugars is an important part of diabetes management. Now we have insulin that is rapid enough to do so.

Tuba: Do you want to give any suggestions to our viewers/diabetic patients regarding the precaution and management of diabetes?

Mark: The management of diabetes, particularly maintaining blood glucose levels in the target range, is a constant balancing act and daily challenge for people with diabetes. People with diabetes who experience high blood glucose levels after meals or struggle to keep their blood glucose in the target range after meals may benefit from incorporating rapid-acting insulin-like Lyumjev into their treatment plans. My patients using Lyumjev are seeing better post-meal blood sugar control. 

Tuba: Highlight the benefits of insulin pumps for diabetic patients.

Mark: Insulin pumps are an important delivery option for people with diabetes, many of whom struggle with high postmeal blood glucose levels. The approval of Lyumjev for use with pumps is exciting news for people with diabetes who use insulin pumps and are considering transitioning to an insulin-like Lyumjev. With Lyumjev we now have insulin that can better address the hyperglycemia after eating.

About Kevin Cammack:

Kevin Cammack leads Eli Lilly’s Connected Care development and commercialization efforts. Kevin received his Bachelor of Arts degree from DePauw University in Greencastle, and his MBA from the Kelley School of Business at Indiana University in Bloomington.

About Mark Warren:

Dr. Warren graduated Magna Cum Laude with his BA from Wake Forest University. He earned his medical degree from the University of North Carolina School of Medicine in Chapel Hill. His Residency in Internal Medicine and Fellowship in Endocrinology was completed at the University of Virginia. Dr. Warren is certified by the American Board of Internal Medicine and in Endocrinology and Metabolism.

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