Benzinga | Aug 16, 2021 07:31AM EDT

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

Insulet Corporation (NASDAQ:PODD) (Insulet or the Company), the leader in tubeless insulin pump technology with its Omnipod(r) brand of products, today announced FDA clearance for use of Eli Lilly and Company's (NYSE:LLY) Lyumjev(r) (insulin lispro-aabc injection) 100 units/mL with Insulet's Omnipod(r) Insulin Management System and Omnipod DASH(r) 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.