Drugs / Vonicog Alfa
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Veyvondi | — | 2018-08-31 | europa.eu ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT07129343 | Oct 2025 → Nov 2027 expected | von Willebrand disease (hereditary or acquired) | Takeda | Recruiting | No outcome recorded |
| Phase 3 | NCT05582993 | Nov 2024 → Apr 2030 expected | von Willebrand disease (hereditary or acquired) | Takeda | Recruiting | No outcome recorded |
| Phase 3 | NCT02973087 | Nov 2017 → Jul 2020 | von Willebrand disease (hereditary or acquired) | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT02932618 | Nov 2017 → Apr 2026 | von Willebrand disease (hereditary or acquired) | Baxalta now part of Shire | Completed | No outcome recorded |
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 9 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Vonicog Alfa | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05582993 ↗ |
| Known as | BAX 111 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107873 ↗ |
| Known as | VEYVONDI | “Recently, however, a novel recombinant VWF (rVWF or vonicog alpha, VONVENDI [US], VEYVONDI [Europe]) has arrived to the market for the treatment of VWD.” PMID 36861346 ↗ Mar 2023 |
| Known as | von Willebrand factor (Recombinant) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02973087 ↗ |
| Known as | vonicog alpha | “Recently, however, a novel recombinant VWF (rVWF or vonicog alpha, VONVENDI [US], VEYVONDI [Europe]) has arrived to the market for the treatment of VWD.” PMID 36861346 ↗ Mar 2023 |
| Known as | VONVENDI | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07129343 ↗ |
| Modality | Protein / enzyme biologic | “recombinant von Willebrand factor” NCT02932618 ↗ |
| Route | Intravenous | “OD participants will receive intravenous (IV) rVWF:RCo” NCT02973087 ↗ |
| Target | VWF | “von Willebrand factor exogenous protein” CHEMBL2107873 ↗ |