Drugs / rVWF:rFVIII
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | VEYVONDI | von Willebrand disease (hereditary or acquired) | 2018-07-02 | “The CHMP submission was based on outcomes from three clinical trials of a total 80 patients with VWD exposed to VEYVONDI.” takeda.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT00816660 | Dec 2008 → Aug 2010 | von Willebrand disease 3 | Baxalta now part of Shire | Completed | No outcome recorded |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rVWF:rFVIII | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00816660 ↗ |
| Known as | Recombinant von Willebrand factor : recombinant FVIII | “Biological: Recombinant von Willebrand factor : recombinant FVIII (rVWF:rFVIII)” NCT00816660 ↗ |
| Modality | Protein / enzyme biologic | “Safety and pharmacokinetics (PK) of recombinant von Willebrand factor (rVWF) combined at a fixed ratio with recombinant factor VIII (rFVIII) were investigated in 32 subjects...” PMID 23777763 ↗ Jun 2013 |