Full Press Release Details
INDIANAPOLIS , Oct. 4, 2017 /PRNewswire/ -- Humalog ® Junior KwikPen ® [insulin lispro injection 100 units/mL] is now available by prescription for the treatment of diabetes in the U.S. This innovation is the latest in the treatment and delivery options Eli Lilly and Company (NYSE: LLY ) offers for people with type 1 or type 2 diabetes. Humalog Junior KwikPen is the only prefilled, disposable half-unit insulin pen.
In June 2017 , the U.S. Food and Drug Administration (FDA) approved Humalog Junior KwikPen for the treatment of diabetes. In September 2017 , the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for Humalog Junior KwikPen in the European Union and is pending final approval, expected later this year.
"Learning how to inject insulin can be overwhelming, especially for newly diagnosed children and their caregivers. People often feel shock and anxiety, and may struggle with the reality of fitting diabetes into daily life," said Sherry Martin , M.D., vice president, Global Medical Affairs, Lilly Diabetes. "We hope to help take away some of the worries about the injection process with Humalog Junior KwikPen. Because it is prefilled, there are fewer steps for people to learn, and the half-unit increments make dosing more precise."
Until now, the only way to deliver half units of insulin with a pen was through a reusable pen, which requires users to remove and load cartridges. Humalog Junior KwikPen offers fine-tuned dosing in a convenient prefilled disposable pen.
Humalog Junior KwikPen enables finer dose adjustment (0.5 vs 1 unit dose increments) for people who take relatively small doses (≤30 units at mealtimes) of Humalog ® U-100 (insulin lispro injection 100 units/mL). The design of Humalog KwikPen meets or exceeds the requirements and standards for needle-based injections set by the International Organization for Standardization.
For more information about Humalog Junior KwikPen, the support resources, please visit www.Humalog.com .
Important Safety Information for Humalog
What is the most important information I should know about Humalog?
Who should not take Humalog?
Before using Humalog, what should I tell my healthcare providers?
How should I use Humalog?
What are the possible side effects of Humalog?
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Humalog is available by prescription only.
For additional information, talk to your healthcare providers and please see accompanying Full Prescribing Information and Patient Prescribing Information .
Please see Instructions for Use included with the Humalog Junior KwikPen.
HI J KP CON ISI 17JUNE2017
About Diabetes Approximately 29 million Americans 1 and an estimated 415 million people worldwide have type 1 and type 2 diabetes. 2 Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diabetes cases. 1 Diabetes is a chronic disease that occurs when the body does not either properly produce or use the hormone insulin.
About Eli Lilly and Company Lilly is a global healthcare leader that unites caring with discovery to 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 www.lilly.com and www.lilly.com/newsroom/social-channels .
Humalog, ® Humalog ® KwikPen ® and Humalog ® Junior KwikPen ® are registered trademarks of Eli Lilly and Company, its subsidiaries, or affiliates, and are available by prescription only.
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Humalog Junior KwikPen and Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with study findings to date, that Humalog Junior KwikPen will receive additional regulatory approvals or that Humalog Junior KwikPen will prove to be commercially successful. 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.
Refer to: Julie Williams , [email protected] , (317) 627-4056
SOURCE Eli Lilly and Company