INDIANAPOLIS and SAN DIEGO, Oct. 7, 2020 /PRNewswire/ --Eli Lilly and Company (NYSE: LLY) and DexCom, Inc. (NASDAQ: DXCM) announced today a joint program for U.S. healthcare providers (HCPs) about Lilly's new rapid-acting mealtime insulin Lyumjev (insulin lispro-aabc injection, 100 units/mL and 200 units/mL), now available in U.S. pharmacies, and Dexcom G6 CGM Systems. The program is designed to help clinicians use data to inform diabetes management, including giving visibility to the benefits of a new mealtime insulin.
HCPs treating type 1 and type 2 diabetes will be able to assess their patients' glucose levels and time in range with Dexcom G6 or Dexcom G6 Pro, either in blinded or unblinded mode, helping them quickly identify adult patients who struggle to manage their postprandial glucose (PPG) levels (glucose levels following meals) and who may benefit from a treatment like Lyumjev. As PPG is often overlooked as a significant contributor to A1C,1 this partnership also aims to elevate PPG monitoring as an important component of diabetes treatment management.
"When it comes to treating diabetes, our partnership with Dexcom has the potential to be meaningful for HCPs who want to help their patients who may be struggling to manage their blood glucose levels after meals," said Adrienne Brown, vice president, U.S. Diabetes and Connected Care, Lilly. "Through this program, we can inspire confidence as clinicians and their patients evaluate new treatment options by showcasing how using these resources together can inform diabetes care."
Lilly and Dexcom will enhance HCP education by jointly sharing information about Lyumjev and the Dexcom G6 and G6 Pro through a variety of channels.
"We are thrilled to partner once again with a leader in diabetes care like Lilly," said Rick Doubleday, chief commercial officer at Dexcom. "Our goal is that the real-time data provided through Dexcom G6 and Dexcom G6 Pro will allow healthcare providers to help their patients with diabetes make more informed decisions, measure and evaluate their time in range, and have more visibility to the potential benefits of transitioning to a new mealtime insulin such as Lyumjev."
Those interested in learning more about Dexcom CGM or getting started on the Dexcom G6 should visit Dexcom.com. The Dexcom G6 is covered by 98 percent of private insurance in the U.S., by Medicare and by Medicaid in many states across the country. Dexcom also recently launched a patient assistance programavailable to currentU.S.customers who lost their health insurance coverage due to the impacts of COVID-19.
Lyumjev is a novel formulation of insulin lispro, developed to speed the absorption of insulin into the bloodstream and reduce A1C levels in adults with diabetes. In clinical studies, Lyumjev provided superior reduction in blood sugar spikes compared with Humalog (insulin lispro injection) when blood sugar was measured 1 and 2 hours after a meal. Lyumjev was approved by the FDA on June 15, 2020. HCPs can now prescribe Lyumjev, which is available for pharmacies nationwide to order. People who have commercial insurance can visit http://www.Lyumjev.com to access the Lyumjev Savings Card. For people without insurance coverage, Lyumjev is also included in the Lilly Insulin Value Program for $35 by calling the Lilly Diabetes Solution Center at (833) 808-1234. Operators at the Solution Center are available Monday through Friday from 8 a.m. to 8 p.m. (ET). Lilly is in discussions with insurance providers to make the new rapid-acting insulin available to as many people as possible.
People with diabetes and their HCPs who have 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 Lilly savings cards and the Dexcom patient assistance program. See the companies' respective websites for additional details. The Lilly savings card is 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. TRICARE is a registered trademark of the Department of Defense (DoD), DHA.
PURPOSE and SAFETY SUMMARY
Important Facts About LYUMJEV (LOOM-jehv) and Humalog (HU-ma-log)
All Lyumjev and Humalog products contain insulin lispro.
Warnings
Do not take Lyumjev or Humalog if you have:
Do not reuse needles or share your insulin injection supplies with other people. This includes your:
You or the other person can get a serious infection. This can happen even if you change the needle.
Do notchange the type of insulin you take or your dose, unless your doctor tells you to. This could cause low or high blood sugar, which could be serious.
Do notuse a syringe to remove Lyumjev or Humalog from your prefilled pen. This can cause you to take too much insulin. Taking too much insulin can lead to severe low blood sugar. This may result in seizures or death.
Lyumjev and Humalog may cause serious side effects. Some of these can lead to death.The possible serious side effects are:
dizziness or lightheadedness
sweating
confusion
headache
blurred vision
slurred speech
shakiness
fast heartbeat
anxiety
irritability
mood change
hunger
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.
a rash over your whole body
trouble breathing
a fast heartbeat
sweating
a faint feeling
shortness of breath
extreme drowsiness
dizziness
confusion
swelling of your face, tongue, or throat
Common side effects
The most common side effects of Lyumjev andHumalog are:
low blood sugar
allergic reactions
reactions where you have injected insulin
skin thickening or pits at the injection
site
itching
weight gain
rash
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 http://www.fda.gov/medwatch.
Before using
Talk with your doctor about low blood sugar and how to manage it. Also tell your doctor:
How to take
Read the Instructions for Use that come with your Lyumjev or Humalog. Be sure to take your Lyumjev or Humalog and check your blood sugar levels exactly as your doctor tells you to. Your doctor may tell you to change your dose because of illness, increased stress, or changes in your weight, diet, or physical activity level. He or she may also tell you to change the amount or time of your dose because of other medicines or different types of insulin you take.
Before injecting your Lyumjev or Humalog
You can inject your insulin dose yourself, or you can have a trained caregiver inject it for you. Make sure you or your caregiver:
When you are ready to inject
Staying safe while taking your Lyumjev or Humalog
To stay safe while taking your insulin, be sure to never inject Lyumjev U-200 in your vein, muscle, or with an insulin pump. Also be sure not to:
Learn more
For more information, call 1-800-545-5979 or go to http://www.Lyumjev.com or http://www.humalog.com
Thissummaryprovidesbasic information about Lyumjev and Humalog. It does not include all information known about these medicines. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other health care provider about your insulin lispro product and how to take it. Your doctor is the best person to help you decide if these medicines are right for you.
Please see Lyumjev Full Prescribing Informationincluding Patient Prescribing Information
Please see Humalog Full Prescribing Informationincluding Patient Prescribing Information
LyumjevTM is a trademark and Humalogis a registeredtrademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
UR HI CON BS 15JUN2020
About Diabetes
Approximately 34 million Americans2 (just over 1 in 10) and an estimated 463 million adults worldwide3 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 Dexcom CGMThe Dexcom G6 provides data-driven insights that are designed to allow people with diabetes to improve their insulin therapy and condition management. Dexcom G6 capabilities include continuous glucose readings, the elimination of routine fingersticks,* proactive and predictive alerts and alarms, remote glucose monitoring and more. The G6 Pro is also the first and only single use, professional CGM available in blinded and unblinded mode that allows healthcare providers to view data about a patient's glucose patterns over a single 10-day period. Through Dexcom CLARITY a diabetes management application offered for both patients and physicians HCPs can access data remotely, regardless of whether their patients are using the personal or professional version of G6.
About DexCom Inc.
DexCom, Inc. empowers people to take control of diabetes through innovative continuous glucose monitoring (CGM) products. Headquartered in San Diego, California, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of patients, caregivers, and clinicians, Dexcom simplifies and improves diabetes management around the world.
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 solutionsfrom medicines and technologies to support programs and more. For the latest updates, visit http://www.lillydiabetes.com/or follow us on Twitter: @LillyDiabetesand Facebook: LillyDiabetesUS.
About Eli Lilly and Company
Lilly is a global healthcare 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.comand lilly.com/newsroom. P-LLY
*If your glucose alerts and readings from the G6 do not match symptoms or expectations, use a blood glucose meter to make diabetes treatment decisions.
Separate Follow app required.
2020 Dexcom, Inc. Dexcom, Dexcom G6 and Dexcom Follow are registered trademarks of Dexcom, Inc. in the U.S., and may be registered in other countries. All rights reserved.
This press release contains forward-looking statements(as that term is defined in the Private Securities Litigation Reform Act of 1995)aboutLyumjev (insulin lispro-aabc injection) as a treatment to improve glycemic control in adults with type 1 and type 2 diabetes, and a joint program between Eli Lilly and Company and DexCom, Inc. designed to help U.S. healthcare providers use data to inform diabetes management and reflects Lilly's current beliefs. However, as with any pharmaceutical product or medical device, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there is no guarantee that Lyumjevwill be commercially successful or receive additional regulatory approvals. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
PP-UR-US-0211 10/2020Lilly USA, LLC 2020. All rights reserved.
References
1. Hershon, K., Hirsh, B., and Odugbesan, O. Importance of Postprandial Glucose in Relation to A1C and Cardiovascular Disease. Clinical Diabetes. 2019; 37 (3): 250-269. Available at: https://clinical.diabetesjournals.org/content/37/3/250.article-info2. 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. 3. International Diabetes Federation. IDF Diabetes Atlas, 9th edn. Brussels, Belgium: International Diabetes Federation, 2019. Available at: http://diabetesatlas.org.
SOURCE Eli Lilly and Company
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