Acton, Mass.-based Insulet said it completed extensive testing to ensure that Fiasp is safe and usable with the Omnipod and Omnipod Dash systems. It’s the first insulin pump in the U.S. to secure this indication.
The Omnipod and Omnipod Dash for adults platforms are continuous insulin delivery systems designed with a tubeless, waterproof, Bluetooth-enabled pod capable of holding up to 200 units of U-100 insulin and a touch-screen personal diabetes manager to control the pod.
Insulet’s Omnipod Dash received FDA 510(k) clearance in June 2018 and the FDA cleared the device as an integrated insulin pump last month.
Novo Nordisk’s Fiasp fast-acting insulin aspart product enters the user’s bloodstream two times faster than its NovoLog insulin and is designed to match a healthy body’s response to a meal, according to Insulet. It is the only fast-acting mealtime insulin injection without a pre-meal dosing recommendation.
Fiasp won FDA approval in 2017 for use in intravenous infusion under professional supervision or by subcutaneous multiple daily injection in adults with diabetes. Last week, it won an expanded label from the FDA for use with infusion pumps by adults with Type 1 or Type 2 diabetes.
“Omnipod can now be used with the full spectrum of insulin, from generic to branded to ultra-fast-acting, and we are thrilled to deliver this additional flexibility for people to use their insulin of choice with the Omnipod System,” Insulet SVP & medical director Dr. Trang Ly said in prepared remarks. “Expanding our labeling to include Fiasp also opens the door for existing Fiasp users to seamlessly transition to an Omnipod System for their insulin delivery needs and further demonstrates our commitment to innovation.”
Shares of PODD were down 0.5% at $145.15 per share while shares of NVO were down -0.3% at $54.06 per share in early-morning trading today.