FDA approves Lyumjev (insulin lispro-aabc injection), Lilly's new rapid-acting insulin
INDIANAPOLIS,?June 15, 2020?/PRNewswire/ --?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.
PURPOSE and SAFETY SUMMARY
Important Facts About?LYUMJEV? (LOOM-jehv) and?Humalog? (HU-ma-log)
Other most common side effects with Humalog include swelling of your hands or feet.
These are not all of the possible side effects.?Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or?www.fda.gov/medwatch.
Before using
Talk with your doctor about low blood sugar and how to manage it. Also tell your doctor:
- Lyumjev is also known as insulin lispro-aabc injection. Humalog is also known as insulin lispro injection.
- Lyumjev is a fast-acting insulin. Lyumjev is used to control high blood sugar in adults with diabetes. Humalog is a fast-acting insulin. Humalog is used to control high blood sugar in adults and children with diabetes. Lyumjev and Humalog are available only with a prescription.
- Lyumjev comes in two strengths: U-100 (100 units per milliliter) and U-200 (200 units per milliliter). The Lyumjev U-200 prefilled pen contains?2 times as much insulin?per 1 milliliter as standard (U-100) insulin. Humalog U-100 contains 100 units of insulin per milliliter. The dose window of the pen shows the number of insulin units to be delivered.
- It is not known if Lyumjev is safe and effective for children. It is not known if Humalog is safe and effective for children with type 2 diabetes or for children younger than 3 years of age with type 1 diabetes as there were no studies done with Humalog in these groups of children. If your doctor decides to give your child any insulin products, he or she may give you special instructions.
- symptoms of low blood sugar (hypoglycemia)
- an allergy to Lyumjev or Humalog or any of their ingredients.
- prefilled pen for use by a single patient
- cartridges
- reusable pen that works with?Lilly?3mL cartridges available for Humalog
- needles
- syringes
- Low blood sugar.?This can cause:
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If you are at risk of having severely low blood sugar, your doctor may prescribe a glucagon emergency kit. These are used when your blood sugar becomes too low and you are unable to take sugar by mouth. Glucagon helps your body release sugar into your bloodstream.
- Severe allergic reaction. Get emergency help right away if you have:
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- Low potassium in your blood.?This can lead to severe breathing problems, irregular heartbeat, and death.
- Heart failure.?Taking diabetes pills called thiazolidinediones (thIE-uh-zOH-li-dEEn-dIE-OHns), or "TZDs," with Lyumjev or Humalog may cause heart failure in some people. This includes people who do not have any heart problems. If you have heart failure, it may get worse if you take TZDs with Lyumjev or Humalog. Tell your doctor if you have any new symptoms of heart failure, or if they get worse. Some symptoms of heart failure include: shortness of breath, swelling of ankles and feet, and sudden weight gain. Your doctor may need to change or stop treatment with TZDs and your insulin lispro product.
- High blood sugar and ketoacidosis for Humalog insulin pump users.?You can have these serious problems when your insulin pump or infusion set stops working. They can also happen if your insulin is no longer effective. For these reasons, always keep extra insulin injection supplies with you.
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- about all of the medicines you take, including over-the-counter medicines, vitamins, and herbal supplements.
- about any other prescription medicines you take, especially ones called TZDs.
- about all of your medical conditions, including if you have heart failure or other heart, liver, or kidney problems.
- if you are pregnant, breastfeeding, or plan to become pregnant or breastfeed.
- Check the insulin label before each injection. This will help you make sure that you are taking the correct insulin.
- Use a new needle for each injection. You can get a serious infection or the wrong dose of insulin if you re-use needles.
- Change (rotate) where you inject your insulin with each dose. This can reduce your chance of getting pits, lumps, or thickened skin where you inject your insulin.?Do not?inject your insulin into the exact same spot or where the skin has pits or lumps.?Avoid?injecting into thickened, tender, bruised, scaly, hard, scarred, or damaged skin.
- Inject Lyumjev under your skin at the beginning of a meal or within 20 minutes after you start eating a meal.
- Inject Humalog under your skin within 15 minutes before or right after you eat a meal.
- mix Lyumjev with other insulins
- drive or use heavy machinery until you know how your Lyumjev or Humalog affects you.
- drink alcohol or use other medicines that contain alcohol when taking your Lyumjev or Humalog.