FDA approves novel, faster-acting insulin lispro injection
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The FDA approved a novel, faster-acting insulin lispro injection to improve glycemic response in adults with type 1 and type 2 diabetes, according to a press release from Eli Lilly.
Insulin lispro-aabc injection 100 U/mL and 200 U/mL (Lyumjev) is a novel formulation of insulin lispro, developed to speed the absorption of insulin into the bloodstream and reduce HbA1c.
“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,” Mark Warren, MD, assistant professor of medicine, Campbell University of Osteopathic Medicine in North Carolina, said in the release. “With its fast onset, Lyumjev is a meaningful development for people who want their insulin to help manage their HbA1c and reduce those post-meal spikes.”
The approval of lispro-aabc injection was based on data from the phase 3 PRONTO-T1D and PRONTO-T2D studies, which compared lispro-aabc injection with insulin lispro injection 100 U/mL (Humalog) in adults with type 1 and type 2 diabetes, respectively, in a treat-to-target trial.
Both studies met the primary endpoint of noninferior HbA1c reduction from baseline compared with Humalog at 26 weeks, when both insulins were dosed at mealtime. Key endpoints were adjusted for multiple testing, including the comparisons of 1- and 2-hour postprandial glucose. In both studies, lispro-aabc demonstrated reduction in blood glucose spikes at 1 hour and 2 hours after a test meal compared with Humalog. The insulins had similar safety and tolerability profiles.
Lispro-aabc injection is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin lispro or one of the excipients in Lyumjev.
Lilly said the faster-acting insulin lispro will be included in the Lilly Insulin Value Program, allowing anyone with commercial insurance and those without insurance to fill their monthly prescription for $35. Once available, 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. EST. The list price of Lyumjev will be the same as the list price for Humalog.
“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,” Adrienne Brown, vice president of U.S. connected care and insulins for Lilly, said in the release. “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. Lilly is working to make Lyumjev available to adults with diabetes in the U.S. as quickly as possible, according to the release.
Perspective
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Susan Cornell, PharmD, CDE, FAPhA, FAADE
As insulin is approaching its 100th birthday, many advances have been made to improve insulin delivery. Although today’s insulins are not yet able to exactly match the rate and delivery of endogenous insulin, the newer insulin products are much closer than 100 years ago. In the past decade, the development focus has been on ultra-rapid-acting insulins — warp-speed insulin — in effort to better match our body’s natural insulin response to food.
It is exciting to know that insulin lispro-aabc has the ability to quickly and effectively respond to food intake, particularly when injected prior to the meal. What was most impressive from the PRONTO trials was the lower rate of late postprandial hypoglycemia with the mealtime insulin lispro-aabc injection. Many people with diabetes, and their health care provider, fear hypoglycemia, especially with mealtime bolus insulins. Having a bolus insulin with a reduced risk for hypoglycemia is noteworthy.
Lastly, any company can have the best product in the world, but if the person who needs that product cannot afford it, the product it not helpful. The fact that this insulin will be included in the Lilly Insulin Value Program will make it accessible and affordable for more people that need it.
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