Insulet (Nasdaq:PODD) announced today that the FDA cleared its Omnipod 5 for individuals aged two years and older with type 1 diabetes.
Acton, Massachusetts-based Insulet’s Omnipod 5 became the first tubeless, wearable automated insulin delivery system cleared for marketing in the U.S. in January. That clearance covered individuals six years of age and older.
In June, the company presented data supporting the use of Omnipod 5 in young children, with the platform significantly improving time in range and reducing HbA1c in children aged 2 through 5.9 years old with type 1 diabetes over 12 months of use.
“We received tremendous first-hand reports of how Omnipod 5 made diabetes management easier for our pivotal trial participants, and the clinical data demonstrated impressive glycemic improvements as well,” Insulet SVP and Medical Director Dr. Trang Ly said in a news release. “This expanded indication for younger children gives us great pride, knowing we can further ease the burden of glucose management for these children and their caregivers with our simple to use, elegant, automated insulin delivery system.”
Omnipod 5 is a tubeless pod enhanced with SmartAdjust technology that integrates with the Dexcom 6 continuous glucose monitor (CGM). It features the Omnipod 5 mobile app with an integrated SmartBolus calculator, too. Users can download the app onto a compatible smartphone or use the Omnipod 5 controller, provided free with the first prescription.
Healthcare professionals can now prescribe Omnipod 5 to their patients with insurance coverage and the patients can access the prescription through the pharmacy channel with no contract and no commitment, according to the company. Insulet said its Omnipod brand is the only insulin pump in the U.S. available through the pharmacy.
“Omnipod 5 has allowed our family to think less about diabetes,” said Kara Hornbuckle, an Omnipod 5 user with two children also using the system. “Omnipod 5 has provided more control and greater peace of mind for all three of us, especially during the nighttime when we are all most vulnerable. The impact that this device has had on my family cannot be understated. We are just so grateful!”
BTIG analyst Marie Thibault wrote in a report that Insulet maintains its “Buy” rating with the positive regulatory news. Shares of PODD were up 1% at $270 apiece before the market opened today.
“We think the totality of this evidence demonstrates that Omnipod 5 is both a valuable and reliable solution for people with Type 1 diabetes across all ages and their caregivers,” she said.