NOVO — Fiasp FDA Review (NDA/BLA 208751, 2026)
NOVO · 2026 · FDA Review (Drugs@FDA)
Report summary
The FDA approved Novo Nordisk's Fiasp (insulin aspart injection) for pediatric use, including continuous subcutaneous insulin infusion (CSII), based on supplemental new drug applications (sNDAs) S-010 and S-011. Clinical trials in adult and pediatric patients with type 1 and type 2 diabetes demonstrated Fiasp's non-inferior glycemic control compared to NovoLog, with faster insulin absorption and earlier glucose-lowering effects. Safety concerns include hypoglycemia, allergic reactions, and injection site reactions, consistent with adult findings. While efficacy was established, some studies noted imbalances in hypoglycemia, particularly nocturnal events with post-meal Fiasp, and infusion site reactions. The approval package includes labeling, warnings, and precautions.
Key findings — cited to the page
| Approval Date | December 19, 2019 | FIASP · United States · p.1 |
| Approval date for pediatric pump use of NovoRapid®/NovoLog® in US | March 14, 2008 | NovoRapid®/NovoLog® · United States · p.335 |
| Supplemental NDA Approval | S-011: addition of continuous subcutaneous insulin infusion (CSII) use in pediatrics | FIASP · United States · p.4 |
| Indication | rapid-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus | FIASP · United States · p.1 |
| Supplemental NDA Approval | S-010: addition of a pediatric indication | FIASP · United States · p.4 |
| Fiasp approval date for adults with diabetes mellitus (subcutaneous and intravenous) | September 29, 2017 | United States · p.19 |
| Fiasp approval date for CSII in adults with diabetes mellitus | October 21, 2019 | United States · p.19 |
| Fiasp approval date for CSII in adults with diabetes mellitus (sNDA 208761-008) | October 21, 2019 | United States · p.9 |
| Postmarketing Requirement Fulfilled | 3253-1 Conduct a 26-week, randomized, controlled efficacy and safety study comparing Fiasp (insulin aspart) administered at mealtime and Fiasp (insulin aspart) administered postmeal to NovoLog administered at mealtime, in combination with insulin degludec, in pediatric patients with type 1 diabetes ages 1 to 17 years (inclusive). | FIASP · United States · p.5 |
| Overall study population from U.S. | 25.6 % | Trial 4101 · United States · p.126 |
| Initial U.S. Approval | 2000 | FIASP · United States · p.10 |
| Asian subjects in study population | 16.2 % | · p.106 |
Source: NOVO ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →