FDA approves efficacy supplement for Novo Nordisk's Awiqli FlexTouch
The agency cleared a priority-reviewed supplemental biologics license application for the insulin icodec injection on October 23, 2026.
The FDA approved a supplemental application for Awiqli FlexTouch, an insulin icodec injection sponsored by Novo Nordisk Inc, with a submission status date of October 23, 2026. The submission was designated a priority review and classified as an efficacy supplement under BLA761326, submission number 1, with a status of approved.1
According to the FDA record, Awiqli FlexTouch is formulated as a solution for injection containing the active ingredient insulin icodec.1
The source does not specify the dosing frequency of the product, the clinical endpoints studied in the supplemental application, or the specific indication changes associated with this approval. No further milestones or regulatory next steps are included in the available record.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.