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# Novo Nordisk Resubmits BLA for Once-Weekly Insulin
- URL: https://www.fdaweb.com/novo-nordisk-resubmits-bla-for-once-weekly-insulin/
- Published: 2025-09-29T12:00:00.000Z
- Updated: 2026-09-14T15:22:53.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5159953

Novo Nordisk has resubmitted a BLA for Awiqli (insulin icodec), a once-weekly basal insulin injection for adults with Type 2 diabetes. If approved, the company says Awiqli would become the first once-weekly basal insulin available in the U.S., offering an alternative to daily injections.

The resubmission follows a 7/2024 complete response letter that Novo Nordisk said at the time cited the product’s manufacturing process and a Type 1 diabetes indication. The company says the resubmission is based on data from its ONWARDS Phase 3a program, which enrolled about 4,000 adults with Type 2 diabetes across five randomized, active-controlled trials. The studies compared Awiqli with daily basal insulin, focusing on changes in A1C levels from baseline as the primary endpoint.