Drugs / ANTIHEMOPHILIC FACTOR, PEGYLATED (MW 20000) HUMAN SEQUENCE RECOMBINANT
ANTIHEMOPHILIC FACTOR, PEGYLATED (MW 20000) HUMAN SEQUENCE RECOMBINANT
also known as
rurioctocog alfa pegol · 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 8
| 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 34 trials · 1 met primary · 1 missed | ||||||
| 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 | Missed primary |
| 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 | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT04784988 | Mar 2022 → Mar 2023 | hemophilia A | Federico II University | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT04690322 Comparator | Apr 2021 → Jul 2027 | hemophilia A | University of Texas Southwestern Medical Center | Withdrawn | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2023-10-31 | Octapharma | Results New Nuwiq® study published in the European Journal of Haematology octapharma.com ↗
Indirect comparison data indicate that personalised prophylaxis with Nuwiq ® may lead to fewer patients with haemophilia A having bleeds than with other recombinant factor VIII products. |
| 2021-02-03 | Takeda | Results Data at EAHAD 2021 Highlight Value of Takeda’s Leading Hematology Portfolio in Clinical Settings and Commitment to Patient-Focused Advancements takeda.com ↗
Results showed that there were no statistically significant differences in prophylactic effectiveness between treatments. |
| 2020-07-11 | Takeda | Results Takeda Provides Updates on Its Pharmacokinetic-guided Prophylaxis Studies at ISTH 2020, Reinforcing Its Commitment to Advancing Personalized Care for People with Bleeding Disorders takeda.com ↗
no new inhibitors were detected after 50 exposure days or 12 months. |
| 2019-12-09 | Takeda | Results Takeda Demonstrates Its Long-Standing Commitment to Advancing Treatments for Rare Bleeding Disorders with Studies Highlighting Real-World Evidence and Investigational Gene Therapy at ASH 2019 takeda.com ↗
In the poster “Real-World Age-Stratified FVIII Consumption and Bleed Outcomes Before and After Switching to Rurioctocog Alfa Pegol in a Retrospective, Observational Study Using US Specialty Pharmacy Data,” ( abstract 2411 ) outcomes found those who switched experienced a significant 40-50% decrease in their annualized bleed rate. |
| 2019-07-08 | Takeda | Results 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 ↗ |
| 2019-02-06 | Takeda | Results Takeda announces results from first-of-its-kind phase IIIb/IV trial PROPEL – a randomized PK-guided prophylaxis study evaluating higher factor VIII levels in hemophilia A– at EAHAD 2019 takeda.com ↗
The study showed that ADYNOVATE prophylaxis targeting 8–12% (HIGH) vs 1–3 % (LOW) trough levels was associated with a trend toward a higher proportion of patients with a total annualized all bleed rate (ABR)=0 (66% HIGH vs 39% LOW; p=0.075). |
| 2018-01-15 | Takeda | Regulatory Shire granted EU marketing authorization for ADYNOVI®▼ [Antihemophilic Factor (Recombinant), PEGylated] for adults and adolescents with Hemophilia A takeda.com ↗
With this approval, Shire is now authorized to market ADYNOVI in the 28 Member States of the European Union (EU), as well as in Iceland, Liechtenstein and Norway. |
| 2017-11-13 | Takeda | Regulatory CHMP recommends EU Marketing Authorization for Adynovi® [Antihemophilic factor (Recombinant), Pegylated] for adults and adolescents with Hemophilia A takeda.com ↗ |
| 2016-12-27 | Takeda | Regulatory Shire announces FDA approval of ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated] for use in Children and Surgical settings takeda.com ↗
The FDA also approved ADYNOVATE for use in surgical settings for both adult and pediatric patients. |
| 2016-08-01 | Takeda | Regulatory SHIRE ANNOUNCES FDA APPROVAL OF ADYNOVATE WITH BAXJECT III RECONSTITUTION SYSTEM takeda.com ↗
Shire plc (LSE: SHP, NASDAQ: SHPG) announced that the U.S. Food and Drug Administration (FDA) has approved the BAXJECT III reconstitution system for ADYNOVATE [Antihemophilic Factor, (Recombinant), PEGylated]. |
| 2016-07-26 | Takeda | Results ADYNOVATE PHASE 3 EFFICACY AND SAFETY DATA IN CHILDREN TO BE SHOWCASED DURING INTERNATIONAL CONGRESS OF THE WORLD FEDERATION OF HEMOPHILIA takeda.com ↗
Twice-weekly prophylactic treatment with ADYNOVATE resulted in reduced dosing frequency in the majority of patients and fewer bleeding episodes. |
| 2015-12-07 | Nektar Therapeutics | Results Baxalta Presents Additional Data on Newly-Approved ADYNOVATE and Plans for New Indications During 57th American Society of Hematology (ASH) Annual Meeting nektar.com ↗
Further analyses of the data from the ADYNOVATE pivotal trial investigated characteristics of patients who achieved zero bleeds in the study. |
| 2015-07-16 | Nektar Therapeutics | Results UPDATE: Baxalta's BAX 855 Pivotal Data Published in Blood Shows Potential to Provide Strong Bleed Prevention with Twice Weekly Dosing for Patients with Hemophilia A nektar.com ↗
Following on initial presentations of the data in 2014, the publication provides a comprehensive overview of the clinical trial results of BAX 855, which will be marketed in the United States under the brand name ADYNOVATE [Antihemophilic Factor (Recombinant), Pegylated] upon approval. |
All press releases naming this drug 13 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 12 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 | PEGylated Recombinant Factor VIII | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01599819 ↗ |
| 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 ↗ |