Drugs / Faster aspart
Faster aspart
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | diabetes mellitus, noninsulin-dependent, 2 | 2017-03-29 | “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, noninsulin-dependent, 2 | — | “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 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials · 1 met primary | ||||||
| Phase 1 | NCT04698018 | Apr 2021 → Jul 2022 | type 1 diabetes mellitus, type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT03723759 | Oct 2018 → Mar 2019 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT03407599 | Jan → Jul 2018 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01682902 | Sep 2012 → Mar 2013 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT04588259 | Oct 2020 → Jul 2022 | type 1 diabetes mellitus, type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT05262595 Comparator | Mar → Aug 2022 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| 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. |
| 2017-01-10 | 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 4 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Faster aspart | “BACKGROUND: Faster aspart is insulin aspart (IAsp) in a new formulation, which” PMID 28055230 ↗ Jan 2017 |
| Known as | Fast-acting Insulin Aspart | “Research Study to Compare a New Medicine "Fast-acting Insulin Aspart" to Another Medicine "Insulin Aspart" in Chinese People With Diabetes” NCT04588259 ↗ |
| Known as | Fiasp | “The 3 formulations of insulin NNC0471-0119 are given as one bolus on top of a constant insulin basal rate and compared to Faster Aspart (Fiasp®).” NCT05262595 ↗1“the reference product called faster aspart 100 U/mL (marketed as Fiasp®)” NCT03723759 ↗ |
| Route | Subcutaneous | “Administration: Subcutaneous infusion.” NCT01682902 ↗ |