FDA Alerts
Trending Topics

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

Posted on

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.

“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.

Read the full press release here.

Source: Eli Lilly