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Insulet's (PODD) Omnipod Gets FDA Nod for Use With Lyumjev

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Insulet Corporation’s (PODD - Free Report) Omnipod and Omnipod DASH insulin management systems recently received FDA’s approval for their use with Eli Lilly and Company’s (LLY - Free Report) Lyumjev (insulin lispro-aabc injection) 100 units/mL. With this regulatory go-ahead, Insulet becomes the only insulin pump manufacturer in the United States to obtain this indication.

Following this, Insulet joined forces with Lilly to add Lyumjev to the label of the Omnipod Insulin Management System and the Omnipod DASH Insulin Management System.

A Few Words on Lumidev and Omnipod

Lyumjev is a fast-acting mealtime insulin that originally got FDA approval in June 2020. This formulation of insulin lispro speeds up the absorption of insulin into the blood stream. Lyumjev helps in controlling glucose levels after meals in adults with diabetes. It more closely matches a body’s typical insulin response to a meal.

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The latest regulatory nod is an expanded label approval for Lumidev to include administration through continuous subcutaneous insulin infusion (CSII) with an insulin pump. Omnipod is the only insulin pump, which received approval for its use with Lyumjev in the United States.

According to the company, this expanded labelling will provide additional choice to the diabetes community to manage their glucose levels and reduce post-meal elevations.

Omnipod’s Industry Prospects

Per a report published in PR Newswire, the global automated insulin delivery system market is expected to see a CAGR of 6% by 2027. Factors like increasing prevalence of diabetes, rise in R&D activities, technological advancements, favorable reimbursement policies and several awareness programs are key factors driving market growth.

Given the market prospects, the favorable pivotal study data for Omnipod 5 bears strategic significance.

Notable Developments

Insulet has achieved several milestones with respect to expanding Omnipod’s market access.

In August 2021, Insulet presented the Omnipod DASH to healthcare providers attending the virtual Australasian Diabetes Congress. Insulet expects to begin taking customer orders for Omnipod DASH by the end of August.

In June 2021, Insulet presented data from pivotal studies concerning the treatment of type 1 diabetes in pre-school children and patients aged six to 70 years with the Omnipod 5 Automated Insulin Delivery System. The company also presented data pertaining to the use of non-automated insulin delivery (AID) system products, the Omnipod System and Omnipod DASH System.

In January 2021, the company launched the Omnipod DASH in Canada. The Omnipod DASH System is a convenient insulin delivery system, which integrates waterproof, tubleless, wearable Pod with a sleek, touchscreen Personal Diabetes Manager to simplify diabetes management. The Pod provides up to three days of insulin delivery without the need for daily injections.

Share Price Performance

The stock has outperformed its industry over the past year. It has gained 39.5% compared with the industry’s 10.5% rise.

Zacks Rank and Key Picks

Currently, Insulet carries a Zacks Rank #4 (Sell).

Two better-ranked stocks from the Medical-Instruments industry include IDEXX Laboratories, Inc. (IDXX - Free Report) and Semler Scientific Inc. (SMLR - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.

IDEXX has a long-term earnings growth rate of 19.9%.

Semler Scientific has a long-term earnings growth rate of 25%.