Drugs / Recombinant Factor VIIa
Recombinant Factor VIIa
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | NovoSeven® | brain injury | 2005-08-11 | “På baggrund af de fortsatte drøftelser med de europæiske registreringsmyndigheder (EMEA) har Novo Nordisk nu trukket sin fase 2-baserede ansøgning om brug af NovoSeven® ved...” novonordisk.com ↗ “The continued consultations with the European regulatory authorities (EMEA) have led Novo Nordisk to withdraw the phase 2-based registration file for NovoSeven® in trauma.” novonordisk.com ↗ |
| Filed | EU (EMA) | NovoSeven® | brain injury | — | “I januar 2005 indsendte Novo Nordisk ansøgning om tilladelse til at markedsføre NovoSeven® i Europa til behandling af ikke-penetrerende traumer” novonordisk.com ↗ “In January 2005, Novo Nordisk filed an application for European marketing approval for the use of NovoSeven® in blunt trauma” novonordisk.com ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00123591 | Jan 2005 → May 2006 | hemorrhagic disease, traumatic brain injury | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07227246 | May 2025 → Jan 2029 expected | intracerebral hemorrhage | Joseph Broderick, MD | Recruiting | No outcome recorded |
| Phase 3 | NCT00243243 | Jan 2006 → Jun 2011 | — | United States Army Institute of Surgical Research | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT01538160 | Feb 2012 → Jul 2015 | coagulation protein disease | Sheba Medical Center | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2025-09-19 | Beijing Tiantan Biological Products Co., Ltd. | Results 国药天坛蓉生rFⅦa瞬效止血，极速守护生命防线 ——止血更迅速、更有效、更安全 tiantanbio.com ↗
临床止血疗效显著，较同类产品，在止血成功率、每次出血平均给药次数、成功止血时间等指标上具有明显优势。 |
| 2021-03-01 | Groupe Lfb | Regulatory LFB announces that the European Medicines Agency (EMA) has accepted for filing the Marketing Authorization Application for eptacog beta (activated), a recombinant coagulation Factor VIIa groupe-lfb.com ↗
LFB today announced that the European Medicines Agency (EMA), the European regulatory authority, has accepted for filing the Marketing Authorization Application for eptacog beta, a recombinant coagulation Factor VIIa (rFVIIa). |
| 2008-06-11 | Novo Nordisk A/S | Results Novo Nordisk discontinues phase 3 clinical trial with NovoSeven® in trauma novonordisk.com ↗
Novo Nordisk today announced the decision to discontinue the phase 3 clinical trial with NovoSeven® for the treatment of bleeding in patients with severe trauma. |
| 2008-06-11 | Novo Nordisk A/S | Results Novo Nordisk indstiller klinisk fase 3-forsøg med NovoSeven® til traumebehandling novonordisk.com ↗
Novo Nordisk meddelte i dag, at virksomheden har besluttet at indstille det kliniske fase 3-forsøg med NovoSeven® til behandling af blødninger hos patienter med svære traumer. |
| 2007-02-26 | Novo Nordisk A/S | Results Phase 3 stroke trial shows that NovoSeven® reduces bleeding in the brain, but does not improve long-term clinical outcomes novonordisk.com ↗
The trial showed that treatment with NovoSeven® significantly reduced intracerebral bleeding compared to placebo treatment. |
| 2007-02-26 | Novo Nordisk A/S | Results Fase 3-forsøg inden for hjerneblødning viser, at NovoSeven® reducerer blødning, men forbedrer ikke det langsigtede behandlingsresultat novonordisk.com ↗
Forsøget viste, at behandling med NovoSeven® medførte en signifikant reduktion af blødningen i forhold til placebobehandling. |
| 2005-08-11 | Novo Nordisk A/S | Regulatory Regnskabsmeddelelse for perioden 1. januar til 30. juni 2005 novonordisk.com ↗
På baggrund af de fortsatte drøftelser med de europæiske registreringsmyndigheder (EMEA) har Novo Nordisk nu trukket sin fase 2-baserede ansøgning om brug af NovoSeven® ved traumebehandling tilbage. |
All press releases naming this drug 9 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | recombinant factor VIIa | “Recombinant factor VIIa (rFVIIa) is a hemostatic agent that has been shown to limit hemorrhage expansion and which, therefore, could potentially reduce morbidity and mortality in tICH.” PMID 18496183 ↗ Apr 2008 |
| Known as | NiaStase | “A Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Dose Escalation Study to Evaluate the Safety and Preliminary Efficacy of Recombinant Factor VIIa...” NCT00123591 ↗ |
| Known as | NovoSeven | “The purpose of the study is to see if a medication (Recombinant Coagulation Factor VIIa or NovoSeven), normally used to stop bleeding in persons with a bleeding disorder, will...” NCT00243243 ↗1“A Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Dose Escalation Study to Evaluate the Safety and Preliminary Efficacy of Recombinant Factor VIIa...” NCT00123591 ↗ |
| Known as | Recombinant Coagulation Factor VIIa | “The purpose of the study is to see if a medication (Recombinant Coagulation Factor VIIa or NovoSeven), normally used to stop bleeding in persons with a bleeding disorder, will...” NCT00243243 ↗ |
| Known as | rFVIIa | “Recombinant factor VIIa (rFVIIa) is a hemostatic agent that has been shown to limit hemorrhage expansion and which, therefore, could potentially reduce morbidity and mortality in tICH.” PMID 18496183 ↗ Apr 20081“intravenous administration of rFVIIa (Novoseven; 90 micrograms/kg, IV push, given at start of first surgical incision and again at 1 hr after start of surgery)” NCT00243243 ↗ |
| Modality | Protein / enzyme biologic | “Recombinant Coagulation Factor VIIa” NCT00243243 ↗ |
| Route | Intravenous | “intravenous administration of rFVIIa (Novoseven; 90 micrograms/kg, IV push, given at start of first surgical incision and again at 1 hr after start of surgery)” NCT00243243 ↗ |