The FDA has granted Beta Bionics breakthrough device designation for its iLet bionic pancreas system.
The designation provides Beta Bionics with priority FDA review. It covers all configurations of the device — insulin-only, glucagon-only, and bi-hormonal, including use with Zealand Pharma’s dasiglucagon, a glucagon analog in a ready-to-use aqueous solution, according to Boston-based Beta Bionics.
The iLet is a pocket-sized, wearable investigational device designed to autonomously control blood sugar in people with diabetes and other conditions. Worn like an insulin pump, iLet allows users to enter only their body weight for the device to begin controlling blood-sugar levels automatically, without requiring the user to count carbohydrates, set insulin delivery rates or deliver bolus insulin for meals or corrections.
The insulin-only and bihormonal configurations are for diabetes, while the glucagon-only configuration may be helpful in rare conditions that often lead to chronic, low blood-sugar conditions, such as congenital hyperinsulinism, according to Beta Bionics.
The Breakthrough Designation for the iLet Bionic Pancreas System contemplates configurations with most insulin analogs approved for pumping as well as dasiglucagon, Zealand Pharma’s stable pumpable glucagon analog, which has a unique stability profile in a ready-to-use aqueous solution.
“We believe the iLet Bionics Pancreas System represents a true breakthrough therapy for the management of glycemia, particularly in type 1 diabetes,” said Beta Bionics president & CEO Ed Damiano in a news release. “We are particularly excited by the possibility that the iLet may be able to provide safer and more effective therapy in far more people than current therapies due to its simplicity of use.”
The first patients with Type 1 diabetes began home use of dasiglucagon in a clinical trial of iLet in May.