Insulet Announces FDA Clearance of Lyumjev® Rapid-Acting Insulin for Use with Omnipod® Products in the United States

Aug 16, 2021

Insulet Announces FDA Clearance of Lyumjev® Rapid-Acting Insulin for Use with Omnipod® Products in the United States

ACTON, Mass.--(BUSINESS WIRE)--Aug. 16, 2021-- Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the leader in tubeless insulin pump technology with its Omnipod® brand of products, today announced FDA clearance for use of Eli Lilly and Company’s (NYSE: LLY) Lyumjev® (insulin lispro-aabc injection) 100 units/mL with Insulet’s Omnipod® Insulin Management System and Omnipod DASH® Insulin Management System. Insulet is the only insulin pump manufacturer in the United States to obtain this indication, providing more flexibility for people with diabetes.

Lyumjev, approved by the FDA in June 2020, is a formulation of insulin lispro developed by Eli Lilly and Company to speed the absorption of insulin into the blood stream. As a rapid-acting insulin, Lyumjev helps control glucose levels after meals in adults with diabetes, so it more closely matches a body’s typical insulin response to a meal.

The FDA has approved an expanded label for the rapid-acting insulin to include administration through continuous subcutaneous insulin infusion (CSII) with an insulin pump, providing more options for people with diabetes to manage their glucose levels and reduce post-meal elevations. Omnipod is the only insulin pump cleared for use with Lyumjev in the United States.

“Rapid-acting insulin is a popular option for people who want added flexibility in their meal-time diabetes regimen,” said Dr. Trang Ly MBBS, FRACP, PhD, Insulet Senior Vice President and Medical Director. “We are thrilled to provide additional choice to the diabetes community, making their lives with diabetes even simpler.”

Insulet collaborated with Lilly to add Lyumjev to the label of the Omnipod Insulin Management System and the Omnipod DASH Insulin Management System.

Please see Lyumjev Full Prescribing Information including Patient Prescribing Information. For additional questions, please call the Lilly Answer Center at 1-800-545-5979.

About Insulet Corporation:

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the disposable Pod provides up to three days of non-stop insulin* delivery, without the need to see or handle a needle. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit and

Forward-Looking Statement:

This press release may contain forward-looking statements concerning Insulet's expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on its current expectations and beliefs concerning future developments and their potential effects on Insulet. There can be no assurance that future developments affecting Insulet will be those that it has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond its control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements, and other risks and uncertainties described in its Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on February 24, 2021 in the section entitled "Risk Factors," and in its other filings from time to time with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of its assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Insulet undertakes no obligation to publicly update or revise any forward-looking statements.

*Additional insulins that are indicated for use with the Pod include: Novolog®, Humalog®, Admelog®, Apidra® and Fiasp®.

© 2021 Insulet Corporation. Omnipod and Omnipod DASH are trademarks or registered trademarks of Insulet Corporation. Lyumjev and Humalog are registered trademarks of Eli Lilly and Company and used with permission. All other trademarks are the property of their respective owners. The use of third-party trademarks does not constitute an endorsement or imply a relationship or other affiliation. All rights reserved.

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Source: Insulet Corporation