Drugs / Fast-acting insulin aspart
Fast-acting insulin aspart
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | diabetes mellitus | 2017-03-29 | “the company has resubmitted the new drug application (NDA) for fast-acting insulin aspart as a class II re-submission to the US Food and Drug Administration (FDA).” novonordisk.com ↗ |
| Rejected (CRL) | US (FDA) | — | diabetes mellitus | — | “In October 2016, Novo Nordisk announced that it had received a Complete Response Letter from the FDA regarding the NDA for fast-acting insulin aspart.” novonordisk.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT03816761 | Feb → May 2019 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT03977727 | Jun 2019 → Mar 2020 | type 1 diabetes mellitus | Texas Diabetes & Endocrinology, P.A. | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT04620967 | Feb 2021 → Jun 2022 | type 1 diabetes mellitus | Kirsten Nørgaard | Unknown | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT04655690 Comparator | Nov 2020 → Nov 2021 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2017-09-29 | Novo Nordisk A/S | Regulatory Novo Nordisks nye hurtigtvirkende måltidsinsulin, Fiasp®, godkendt i USA novonordisk.com ↗
Bagsværd, den 29. september 2017 - Novo Nordisk meddeler i dag, at de amerikanske sundhedsmyndigheder, FDA, har godkendt Fiasp® (hurtigtvirkende insulin aspart), en ny hurtigtvirkende måltidsinsulin, til behandling af voksne med diabetes. |
| 2017-09-29 | Novo Nordisk A/S | Regulatory Novo Nordisk's new fast-acting mealtime insulin Fiasp® approved in the US novonordisk.com ↗
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Fiasp® (fast-acting insulin aspart), a new fast-acting mealtime insulin, for the treatment of adults with diabetes. |
| 2017-03-29 | Novo Nordisk A/S | Regulatory Novo Nordisk resubmits new drug application for fast-acting insulin aspart in the US novonordisk.com ↗
Novo Nordisk today announced that the company has resubmitted the new drug application (NDA) for fast-acting insulin aspart as a class II re-submission to the US Food and Drug Administration (FDA). |
| 2017-01-10 | Novo Nordisk A/S | Regulatory Fiasp® (hurtigtvirkende insulin aspart) godkendt i Europa novonordisk.com ↗
Bagsværd, den 10. januar 2017 - Novo Nordisk meddeler i dag, at Europa-Kommissionen har givet markedsføringstilladelse til Fiasp® til behandling af diabetes hos voksne. |
| 2017-01-10 | Novo Nordisk A/S | Regulatory Fiasp® (fast-acting insulin aspart) approved in Europe novonordisk.com ↗
Novo Nordisk today announced that the European Commission has granted marketing authorisation for Fiasp® for the treatment of diabetes in adults. |
| 2016-11-11 | Novo Nordisk A/S | Regulatory Novo Nordisk receives positive opinion from the European regulatory authorities for Fiasp® (fast-acting insulin aspart) for the treatment of diabetes novonordisk.com ↗
The CHMP recommends Fiasp®, the intended brand name for fast-acting insulin aspart, to be indicated for use as the bolus component of basal-bolus therapy in combination with basal insulin and for continuous subcutaneous insulin infusion via an insulin pump. |
| 2016-11-11 | Novo Nordisk A/S | Regulatory Novo Nordisk får positiv udtalelse fra de europæiske lægemiddelmyndigheder om Fiasp® (hurtigtvirkende insulin aspart) til behandling af diabetes novonordisk.com ↗
CHMP anbefaler, at Fiasp®, det planlagte varemærke for hurtigtvirkende insulin aspart, indiceres til brug som boluskomponenten i basal-bolus-behandling i kombination med basalinsulin og til kontinuerlig subkutan infusion via en insulinpumpe. |
All press releases naming this drug 9 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fast-acting insulin aspart | “This is a single-center randomized open label active-controlled crossover trial comparing efficacy and safety of fast acting insulin aspart (FA) (FIASP®) versus insulin aspart...” PMID 33090016 ↗ Mar 2021 |
| Known as | faster aspart | “We investigated the safety of, and glucose control by, the insulin-only configuration of the iLet® bionic pancreas delivering fast-acting insulin aspart (faster aspart), using...” PMID 34146238 ↗ Jun 2021 |
| Known as | Fiasp | “This is a single-center randomized open label active-controlled crossover trial comparing efficacy and safety of fast acting insulin aspart (FA) (FIASP®) versus insulin aspart...” PMID 33090016 ↗ Mar 20212“Participants will get a fixed dose of 0.2 units of fast-acting insulin aspart (Fiasp®) per kilogram body weight” NCT04655690 ↗ “Fast-acting insulin aspart (Fiasp) in insulin pump” NCT04620967 ↗ |
| Modality | Protein / enzyme biologic | “fast-acting insulin aspart” NCT04655690 ↗ |
| Route | Subcutaneous | “continuous subcutaneous insulin infusion” NCT03977727 ↗ |