FDA advisors vote against weekly insulin for type 1 diabetes
In other diabetes-related actions, the FDA recently authorized marketing of an app for automated insulin delivery and warned about software issues with an existing app and insulin pump.
An FDA advisory committee voted against approval of weekly insulin icodec to treat type 1 diabetes on May 24. The panel of independent experts expressed concern about the risk of hypoglycemia with the weekly insulin formulation developed by Novo Nordisk, and they voted seven to four that current data do not show its benefits outweigh its risks, according to Reuters.
On May 23, the FDA authorized marketing of a new prescription-only mobile app for automated insulin dosing to help manage type 1 diabetes. The app, CamAPS FX by CamDiab Ltd., is the first of its kind for use in pregnant patients who may have complications from type 1 diabetes. The device works with an integrated continuous glucose monitor to control a compatible insulin pump. The app is designed to be compatible with other interoperable devices that meet prespecified criteria, an FDA release said.
The FDA also recently notified clinicians and patients of a class I recall of version 2.7 of the Apple iOS t:connect mobile app used in conjunction with t:slim X2 insulin pump with control-IQ technology by Tandem Diabetes Care, Inc. An issue with the software may cause a cycle in which the mobile app crashes and is automatically relaunched by the iOS operating system, which may result in pump battery drain and may lead to the pump shutting down sooner than typically expected.