Drugs / ANTIHEMOPHILIC FACTOR, PEGYLATED (MW 20000) HUMAN SEQUENCE RECOMBINANT
ANTIHEMOPHILIC FACTOR, PEGYLATED (MW 20000) HUMAN SEQUENCE RECOMBINANT
also known as
rurioctocog alfa pegol · BAX 855 · Adynovate · Adynovi · PEGylated Recombinant Factor VIII · ADYNOVATE- antihemophilic factor (recombinant) pegylated · Pegylated rfviii
Protein / enzyme biologic targets F8
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Adynovi | — | 2018-01-08 | europa.eu ↗ |
Trials 11 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05042440 | Aug → Nov 2021 | hemophilia A | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT04015492 | Aug → Oct 2019 | hemophilia A | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT01599819 | Sep 2011 → Jul 2012 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01736475 | Jan 2013 → Jul 2014 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT05707351 | Mar 2023 → Sep 2024 | hemophilia A | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT02585960 | Nov 2015 → Aug 2018 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 3 | NCT02615691 | Nov 2015 → Oct 2024 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 3 | NCT02210091 | Oct 2014 → Oct 2015 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 3 | NCT01913405 | Dec 2013 → Sep 2016 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 3 | NCT01945593 | Oct 2013 → Mar 2018 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT04784988 | Mar 2022 → Mar 2023 | hemophilia A | Federico II University | Completed | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT04690322 Comparator | Apr 2021 → Jul 2027 | hemophilia A | University of Texas Southwestern Medical Center | Withdrawn | No outcome recorded |
Press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-07-08 | Takeda | Takeda Unveil New Data from the PROPEL Study at ISTH 2019, Reinforcing the Potential Benefit for Personalized Prophylaxis with ADYNOVATE in Severe Hemophilia A takeda.com ↗ |
| 2018-01-15 | Takeda | Shire granted EU marketing authorization for ADYNOVI®▼ [Antihemophilic Factor (Recombinant), PEGylated] for adults and adolescents with Hemophilia A takeda.com ↗ |
| 2017-11-13 | Takeda | CHMP recommends EU Marketing Authorization for Adynovi® [Antihemophilic factor (Recombinant), Pegylated] for adults and adolescents with Hemophilia A takeda.com ↗ |
| 2016-12-27 | Takeda | Shire announces FDA approval of ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated] for use in Children and Surgical settings takeda.com ↗ |
| 2016-08-01 | Takeda | SHIRE ANNOUNCES FDA APPROVAL OF ADYNOVATE WITH BAXJECT III RECONSTITUTION SYSTEM takeda.com ↗ |
| 2016-07-26 | Takeda | ADYNOVATE PHASE 3 EFFICACY AND SAFETY DATA IN CHILDREN TO BE SHOWCASED DURING INTERNATIONAL CONGRESS OF THE WORLD FEDERATION OF HEMOPHILIA takeda.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ANTIHEMOPHILIC FACTOR, PEGYLATED (MW 20000) HUMAN SEQUENCE RECOMBINANT | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594584 ↗ |
| Known as | Adynovate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04690322 ↗ |
| Known as | ADYNOVATE- antihemophilic factor (recombinant) pegylated | “ADYNOVATE- antihemophilic factor (recombinant) pegylated” NCT04690322 ↗ |
| Known as | Adynovi | “start a prophylaxis with Adynovi® targeting a 12% FVIII through level (PROPEL-like arm)” NCT04784988 ↗1“Rurioctocog alfa pegol (Adynovi)” NCT04015492 ↗ |
| Known as | BAX 855 | “BAX 855, Baxalta's pegylated full-length recombinant FVIII (rFVIII), was designed to increase half-life and, thus, reduce the frequency of prophylactic infusions while...” PMID 26157075 ↗ Jul 2015 |
| Known as | PEGylated Recombinant Factor VIII | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02210091 ↗ |
| Known as | Pegylated rfviii | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594584 ↗ |
| Known as | rurioctocog alfa pegol | “OBJECTIVE: To investigate the benefit of PK-guided prophylaxis with rurioctocog alfa pegol targeting two FVIII trough levels in specific patient subgroups in a post hoc...” PMID 37465396 ↗ Jul 20233“Immunogenicity, safety, and efficacy of rurioctocog alfa pegol in previously untreated patients with severe hemophilia A: interim results from a phase 3, prospective,...” PMID 37646148 ↗ Sep 2023 |
| Action | Restore | “This drug will be used for extended half-life factor VIII-based replacement therapy.” NCT04690322 ↗ |
| Modality | Protein / enzyme biologic | “BAX 855, Baxalta's pegylated full-length recombinant FVIII (rFVIII), was designed to increase half-life” PMID 26157075 ↗ Jul 2015 |
| Route | Intravenous | “received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV” NCT02615691 ↗ |
| Target | F8 | “Coagulation factor VIII exogenous protein” CHEMBL4594584 ↗ |