Novo Nordisk Resubmits Awiqli® and Submits Mim8 BLA to FDA for Diabetes and Hemophilia A

Novo Nordisk announced the resubmission of Awiqli® (insulin icodec) and the submission of Mim8 Biologics License Applications (BLA) to the U.S. FDA. Awiqli® targets adults with type 2 diabetes, while Mim8 is designed for patients with hemophilia A.

Awiqli® (Insulin Icodec) – Resubmission

Awiqli® is a long-acting basal insulin developed from oral insulin OI338, designed for once-weekly injections. Molecular modifications include:

1. B-chain 18C fatty acid → 20C fatty acid to enhance albumin binding.
2. Tyr16 → His16 to reduce insulin receptor affinity.

Background & Clinical Data

• Initial BLA: Submitted April 2023 for type 1 and type 2 diabetes.
• CRL: FDA issued a Complete Response Letter in July 2024 citing manufacturing and type 1 diabetes indication issues.
• Resubmission: September 2025 BLA focuses solely on type 2 diabetes, supported by ONWARDS 1–5 Phase 3 studies, showing non-inferior or superior HbA1c reductions versus daily basal insulin with no significant increase in severe hypoglycemia.

If approved, Awiqli® would become the first once-weekly basal insulin in the U.S., reducing patient injection burden from 365 to 52 doses per year.

Mim8 – Hemophilia A

Mim8 is a non-factor bispecific antibody using Genmab’s DuoBody platform to mimic FVIIIa by bridging FIXa and FX. Its coagulation activity is ~15× that of emicizumab.

FRONTIER Phase 3 Highlights

• FRONTIER 2 (26 weeks): Weekly/monthly dosing reduced treated bleeds by 97%/99% in previously untreated hemophilia A patients, with 86–95% reporting no treated bleeds.
• FRONTIER 3 (1–11 years): Weekly dosing yielded mean ABR 0.53, median ABR 0, 74.3% of patients bleed-free.
• FRONTIER 4 (adolescents & adults): Every two-week dosing, mean ABR 0.4, median ABR 0, 84% bleed-free.
• FRONTIER 5: Patients switched from emicizumab to Mim8 without washout, showing good tolerability.

Globally, hemophilia affects ~1.125 million patients, with hemophilia A representing 80–85%; up to 30% may have inhibitors. Non-factor therapies remain limited, including emicizumab, concizumab, and fitusiran. Mim8 adds a promising option to this small class.

Summary

Novo Nordisk’s Awiqli® resubmission and Mim8 submission reinforce its commitment to innovative therapies. Awiqli® could simplify diabetes care with once-weekly injections, while Mim8 offers highly effective non-factor prophylaxis for hemophilia A.

References:

https://www.prnewswire.com/news-releases/novo-nordisk-resubmits-awiqli-to-the-fda-with-potential-to-be-the-first-once-weekly-basal-insulin-treatment-for-adults-with-type-2-diabetes-302568645.html

https://www.prnewswire.com/news-releases/novo-nordisk-submits-biologics-license-application-bla-to-fda-for-mim8-an-investigational-prophylaxis-treatment-for-people-living-with-hemophilia-a-with-or-without-inhibitors-302568838.html