Drugs / Recombinant von Willebrand Factor
Recombinant von Willebrand Factor
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) | 2017-06-22 | “the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for VEYVONDI to prevent and treat bleeding episodes” takeda.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06118372 | Oct 2024 → Dec 2026 expected | blood coagulation disease | University of Virginia | Recruiting | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT02283268 | Apr 2015 → Jul 2016 | hereditary von Willebrand disease | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 3 | NCT01410227 | Nov 2011 → Feb 2014 | hereditary von Willebrand disease | Baxalta now part of Shire | Completed | Met primary |
| Comparator or background therapy2 trials | ||||||
| Phase 3 | NCT04344860 Comparator | Jun 2021 → Aug 2024 | von Willebrand disease (hereditary or acquired) | Nicoletta C Machin | Completed | No outcome recorded |
| Phase 3 | NCT02606045 Comparator | Feb 2019 → Apr 2022 | von Willebrand disease (hereditary or acquired) | Margaret Ragni | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2025-09-05 | Takeda | Regulatory U.S. FDA Approves Expanded Indication for VONVENDI® [von Willebrand factor (Recombinant)] for Adults and Children with Von Willebrand Disease takeda.com ↗ |
| 2021-07-20 | Takeda | Results Takeda Data at ISTH 2021 Highlight the Benefits of Prophylaxis for Patients with Rare Bleeding Disorders takeda.com ↗
Results showed that prophylaxis with rVWF effectively reduced spontaneous, treated annualized bleeding rates (sABRs) in patients previously treated OD, and the same level of hemostatic control was maintained in patients who switched from prophylaxis with pdVWF. |
| 2018-09-12 | Takeda | Regulatory Shire granted EU marketing authorization for VEYVONDI® [vonicog alfa, recombinant von Willebrand factor] for adults with von Willebrand disease takeda.com ↗ |
| 2018-07-02 | Takeda | Regulatory CHMP recommends EU marketing authorization for VEYVONDI® [vonicog alfa, recombinant von Willebrand factor] for adults with von Willebrand disease takeda.com ↗
has issued a positive opinion recommending the granting of marketing authorization in the European Union (EU) for VEYVONDI [vonicog alfa, recombinant von Willebrand factor] (rVWF) |
| 2018-05-22 | Takeda | Results SHIRE RELEASES DATA AT THE WORLD FEDERATION OF HEMOPHILIA CONGRESS 2018 EVALUATING VONVENDI® IN ADULTS WITH VON WILLEBRAND DISEASE DURING AND AFTER SURGERY takeda.com ↗
Results from the study showed that all 15 study participants had overall/intraoperative hemostatic efficacy ratings of "excellent" (as good as or better than expected) or "good" (probably as good as expected). |
| 2018-04-17 | Takeda | Regulatory FDA approves VONVENDI® [von Willebrand factor (recombinant)] for perioperative management of bleeding in adult patients with von Willebrand disease[1] takeda.com ↗
The expanded approval of VONVENDI represents a new treatment option for the surgical setting that can be tailored to each patient’s individual needs, |
| 2017-06-22 | Takeda | Regulatory Shire announces EMA validation of VEYVONDI™ [von Willebrand factor (Recombinant)] Marketing Authorization Application for treatment of von Willebrand disease takeda.com ↗
Shire plc (LSE: SHP, NASDAQ: SHPG), the leading biotechnology company focused on serving individuals with rare diseases, today announced that the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for VEYVONDI to prevent and treat bleeding episodes and peri-operative bleeding in adults (age 18 and older) diagnosed with von Willebrand Disease (VWD), the most common inherited bleeding disorder. |
| 2016-12-02 | Takeda | Results Topline results of Phase 3 investigational study of VONVENDI™ [von Willebrand factor (Recombinant)] meets primary endpoint effectively controlling bleeding and blood loss during surgical procedures takeda.com ↗
The study met its primary endpoint and indicates that VONVENDI effectively controlled bleeding and blood loss during an operation in adults undergoing major, minor and oral elective surgical procedures. |
All press releases naming this drug 8 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Recombinant von Willebrand factor | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01410227 ↗ |
| Known as | recombinant VWF | “The primary objectives are to evaluate the safety, tolerability, and pharmacokinetics of recombinant vWF in adult ECMO patients.” NCT06118372 ↗ |
| Known as | rVWF | “Recombinant von Willebrand Factor (rVWF)” NCT02283268 ↗1“rVWF” NCT01410227 ↗ |
| Action | Restore | “peri- and postoperative substitution regimen” NCT02283268 ↗ |
| Modality | Protein / enzyme biologic | “a recombinant von Willebrand factor (rVWF)” PMID 26239086 ↗ Aug 2015 |
| Route | Intravenous | “rVWF will be administered by intravenous bolus infusion” NCT02283268 ↗ |