FDA approves Lyumjev™ (insulin lispro-aabc injection), Lilly's new rapid-acting insulin

INDIANAPOLIS, IN, USA I June 15, 2020 I The U.S. Food and Drug Administration (FDA) has approved Lyumjev (insulin lispro-aabc injection, 100 units/mL and 200 units/mL), Eli Lilly and Company's (NYSE: LLY) new rapid-acting insulin indicated to improve glycemic control in adults with type 1 and type 2 diabetes. Lyumjev is a novel formulation of insulin lispro, developed to speed the absorption of insulin into the blood stream and reduce A1C levels. As a rapid-acting mealtime insulin, Lyumjev controls high blood sugar levels after meals in adults with diabetes, similar to how natural insulin works after meals in people without diabetes.

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"Thanks to advances in glucose monitoring, the people with diabetes I treat in my practice are able to more clearly see the blood glucose spikes that happen naturally after a meal," said Mark Warren, M.D., Assistant Professor of Medicine, Campbell University of Osteopathic Medicine. "With its fast onset, Lyumjev is a meaningful development for people who want their insulin to help manage their A1C and reduce those post-meal spikes."

The approval of Lyumjev was based on data from the Phase 3 studies PRONTO-T1D and PRONTO-T2D, which were randomized, active controlled, treat-to-target comparisons of Lyumjev and Humalog® (insulin lispro injection, 100 units/mL) in adults with type 1 and type 2 diabetes, respectively. Both studies met the primary endpoint of noninferior A1C reduction from baseline compared to Humalog at 26 weeks, when Lyumjev and Humalog were dosed at mealtime. Key endpoints were adjusted for multiple testing, including the comparisons of one- and two-hour postprandial glucose. In both studies, Lyumjev demonstrated superior reduction in blood glucose spikes at both one hour and two hours after a test meal compared to Humalog.

In Phase 3 studies, Lyumjev and Humalog had similar safety and tolerability profiles. Lyumjev is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin lispro or one of the excipients in Lyumjev. Hypoglycemia, which can be serious and life-threatening, is the most common adverse reaction associated with insulins, including Lyumjev.

"We are proud to build on our long heritage of developing new insulins with the approval of Lyumjev, an important new treatment option to help control post-meal blood sugar levels," said Leonard Glass, M.D., F.A.C.E., vice president of Medical Affairs, Lilly. "Keeping blood sugar in the target range following meals can be challenging for people living with diabetes, and the approval of Lyumjev underscores our commitment to meeting their needs."

Lyumjev will be included in the Lilly Insulin Value Program, allowing anyone with commercial insurance and those without insurance at all to fill their monthly prescription of Lyumjev for $35. When Lyumjev is available in U.S. pharmacies, this savings option can be obtained by calling the Lilly Diabetes Solution Center at (833) 808-1234, Monday through Friday from 8 a.m. to 8 p.m. (ET). The list price of Lyumjev will be the same as the list price for Humalog. Lilly is in discussions with insurance providers to make Lyumjev available to as many people as possible.

"Lilly is committed to ensuring all of our insulins, including Lyumjev, are accessible to people living with diabetes through our wide range of affordability options, such as the Lilly Insulin Value Program," said Adrienne Brown, vice president, U.S. Connected Care and Insulins, Lilly. "We want people who use Lilly insulin and need help affording their medicine to know that we're here to support them."

Lyumjev has been approved by regulatory authorities in several global markets, including Japan and the European Union in March 2020. Lilly is currently working to make Lyumjev available to adults with diabetes in the U.S. as quickly as possible.

Patients and healthcare providers with questions about Lyumjev can visit http://www.Lyumjev.com or call The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979), Monday through Friday from 9 a.m. to 8 p.m. ET.

Terms, conditions, and limitations apply to savings cards. Not available to those patients with government insurance such as Medicaid, Medicare, Medicare Part D, TRICARE®/CHAMPUS, Medigap, DoD, or any State Patient or Pharmaceutical Assistance Program.

About the Lyumjev clinical studies
PRONTO-T1D and PRONTO-T2D were randomized, active controlled, treat-to-target comparisons of Lyumjev (insulin lispro-aabc injection, 100 units/mL) and Humalog (insulin lispro injection, 100 units/mL), both in combination with either insulin glargine or insulin degludec in adults 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 other important treatment effects, such as rates of hypoglycemia and post-meal glucose control. A subset of patients randomized to PRONTO-T1D participated in an evaluation of 24-hour ambulatory glucose profiles captured with blinded continuous glucose monitoring (CGM) over a two-week period. Both studies met the primary endpoint of noninferior A1C reduction from baseline compared to Humalog at 26 weeks, when Lyumjev and Humalog were dosed at mealtime. Key endpoints were adjusted for multiple testing, including the comparisons of one- and two-hour postprandial glucose. In both studies, Lyumjev demonstrated superior reduction in blood glucose spikes at both one hour and two hours after a test meal compared to Humalog. Additionally, in studies evaluating the time action profile of this new insulin, Lyumjev appeared in the blood stream approximately one minute after injection.

About Diabetes
Approximately 34 million Americans1 (just over 1 in 10) and an estimated 463 million adults worldwide2 have diabetes. Type 2 diabetes is the most common type internationally, accounting for an estimated 90 to 95 percent of all diabetes cases in the United States alone1. Diabetes is a chronic disease that occurs when the body does not properly produce or use the hormone insulin.

About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research, collaboration and quality manufacturing we strive to make life better for people affected by diabetes and related conditions. We work to deliver breakthrough outcomes through innovative solutions—from medicines and technologies to support programs and more. For the latest updates, visit http://www.lillydiabetes.com/or follow us on Twitter: @LillyDiabetes and Facebook: LillyDiabetesUS.

About Eli Lilly and Company
Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom. P-LLY 

References

1. Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2020. Atlanta, GA: Centers for Disease Control and Prevention, U.S. Dept. of Health and Human Services; 2020.

2. International Diabetes Federation. IDF Diabetes Atlas, 9th edn. Brussels, Belgium: International Diabetes Federation, 2019. Available at: http://diabetesatlas.org.

SOURCE: Eli Lilly

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