Drugs / ADVATE
ADVATE
also known as
BAY 81-8973 · Octocog alfa · Kogenate FS · BAY14-2222 · Kogenate · Kovaltry · Recombinate · Antihemophilic Factor (Recombinant) · +7 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Kogenate Bayer | — | 2000-08-04 | europa.eu ↗ |
Trials 31
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials · 2 met primary | ||||||
| Phase 1 | NCT05042440 | Aug → Nov 2021 | hemophilia A | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT04864743 | Jun → Oct 2021 | severe hemophilia A | Hangzhou Gensciences Biopharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05251090 | Jun → Nov 2021 | hemophilia A | Hangzhou Gensciences Biopharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02716194 | Mar 2016 → Jan 2017 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 1 | NCT02483208 | Jun → Jul 2015 | hemophilia A | Bayer | Completed | Met primary |
| Phase 1 | NCT01184820 | Oct 2010 → Oct 2011 | hemophilia A | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT00837356 | Mar → Oct 2009 | hemophilia A | Novo Nordisk A/S | Completed | Met primary |
| Phase 1 | NCT00629837 | Sep 2005 → Mar 2006 | hemophilia A | Bayer | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03205163 | Aug 2017 → Nov 2018 | hemophilia A | Bioverativ, a Sanofi company | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00717626 | Jul 2008 → Apr 2011 | hemophilia A | The Hospital for Sick Children | Completed | No outcome recorded |
| Phase 2/34 trials · 2 met primary | ||||||
| Phase 2/3 | NCT01736475 | Jan 2013 → Jul 2014 | hemophilia A | Baxalta now part of Shire | Completed | Met primary |
| Phase 2/3 | NCT01486927 | Feb 2012 → Dec 2014 | hemophilia A | CSL Behring | Completed | Met primary |
| Phase 2/3 | NCT00157040 | Jun 2002 → Jan 2005 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 2/3 | NCT00157053 | Nov 2001 → Aug 2004 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 37 trials · 2 met primary | ||||||
| Phase 3 | NCT02306694 | Dec 2014 → Apr 2018 | bone disorder, hemophilia | Oregon Health and Science University | Completed | No outcome recorded |
| Phase 3 | NCT01376700 | Aug 2011 → Nov 2012 | hemophilia A | Baxalta now part of Shire | Terminated | No outcome recorded |
| Phase 3 | NCT01311648 | Jun 2011 → Sep 2019 | hemophilia A | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT01233258 | Jan 2011 → Dec 2012 | hemophilia A | Bayer | Completed | Met primary |
| Phase 3 | NCT01181128 | Nov 2010 → Aug 2012 | severe hemophilia A | Bioverativ Therapeutics Inc. | Completed | Met primary |
| Phase 3 | NCT01029340 | Dec 2009 → Jun 2012 | hemophilia A | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00606060 | Jul 2004 → May 2005 | hemophilia | Bayer | Completed | No outcome recorded |
| Phase 49 trials · 1 met primary | ||||||
| Phase 4 | NCT06864975 | Mar 2025 → Mar 2028 expected | hemophilia A | Runhui WU | Recruiting | No outcome recorded |
| Phase 4 | NCT04985682 | Jan 2022 → Feb 2023 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 4 | NCT04565236 | Sep 2020 → Mar 2024 | hemophilia A | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT02170402 | Jun 2014 → May 2016 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 4 | NCT02314325 | Apr 2014 → May 2016 | severe hemophilia A | St. James's Hospital, Ireland | Unknown | No outcome recorded |
| Phase 4 | NCT00632814 | Jun 2007 → Sep 2009 | hemophilia A | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00621673 | May → Oct 2006 | hemophilia A | Bayer | Terminated | No outcome recorded |
| Phase 4 | NCT00289536 | Feb 2006 → Apr 2007 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 4 | NCT00586521 | Feb 2006 → Mar 2008 | hemophilia A | Bayer | Completed | Met primary |
| Phase not applicable1 trial | ||||||
| — | NCT02282410 | Dec 2014 → Dec 2016 | hemophilia A | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Unknown | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 2 | NCT00989196 Comparator | May 2010 → Oct 2011 | hemophilia A | Octapharma | Completed | No outcome recorded |
| Phase 3 | NCT07129343 Background | Oct 2025 → Nov 2027 expected | von Willebrand disease (hereditary or acquired) | Takeda | Recruiting | No outcome recorded |
| Phase 3 | NCT05582993 Background | Nov 2024 → Apr 2030 expected | von Willebrand disease (hereditary or acquired) | Takeda | Recruiting | No outcome recorded |
| Phase 4 | NCT00916032 Comparator | Jun 2009 → Apr 2010 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
| — | NCT01051544 Comparator | Sep 2009 → Jun 2020 | severe hemophilia A | City of Hope Medical Center | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 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 ↗
Seven year AHEAD study data [ABS034] showed that prophylactic antihemophilic factor (recombinant), rAHF (ADVATE), achieved lower annualized bleeding rates (ABRs) and annualized joint bleeding rates (AJBRs) than on-demand treatment in all patients with severe hemophilia A. |
| 2020-06-15 | Takeda | Results Takeda Provides Updates on its Hemophilia Studies at WFH 2020, Reinforcing its Commitment to Putting Patients First and Supporting Personalized Care for People with Bleeding Disorders takeda.com ↗
The data we presented at WFH 2020 continue to add to the body of evidence for the management of hemophilia, a bleeding disorder that affects at least 210,000 people worldwide as of 2018 and potentially a lot more. |
| 2018-12-01 | Takeda | Results Initial Data from Shire Collaboration Identifies Key Biomarkers That Affect Bleeding Patterns, Response to Treatment for Hemophilia A takeda.com ↗
The study also supports the feasibility of using limited, 2-sample PK profiling to capture accurate PK curves that can then be utilized to guide individualized, PK-guided prophylaxis. |
| 2013-02-08 | Sobi, Inc. | Results NEW PHASE 3 DATA REINFORCE LONG-LASTING PROTECTION FROM BLEEDING FOR PATIENTS WITH HEMOPHILIA A AND B sobi.com ↗
The A-LONG results confirm the long-lasting characteristics of rFVIIIFc; specifically, the data show that rFVIIIFc stays in the body for 50 percent longer than Advate(®) [antihemophilic factor (recombinant), plasma/albumin-free method], the most frequently used factor VIII therapy. |
| 2009-08-17 | CSL Behring | Regulatory Helixate FS Receives FDA Approval for Routine Prophylaxis in Children with Hemophilia A csl.com ↗
This new indication was granted by the FDA after determining Helixate FS is safe and effective for routine prophylaxis, which can reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A. |
All press releases naming this drug 23 releases
Evidence & citations 19 cited values
Every value below carries the sentence it was read from. 39 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ADVATE | “OBJECTIVE: To evaluate the efficacy and safety of ADVATE rAHF-PFM (Baxter Healthcare Corporation), a recombinant FVIII concentrate manufactured without human or bovine...” PMID 19216617 ↗ Mar 200917“A phase 1 study compared the pharmacokinetic (PK) profile of BAX 855 with that of licensed rFVIII (Advate).” PMID 26157075 ↗ Jul 2015 “Weekly infusions of ADVATE.” NCT01376700 ↗ “Advate” NCT01051544 ↗ |
| Known as | Antihemophilic Factor (Recombinant) | “ADVATE [Antihemophilic Factor (Recombinant)]” NCT02314325 ↗ |
| Known as | Antihemophilic factor, recombinant, manufactured protein-free | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00289536 ↗ |
| Known as | BAY 81-8973 | “BAY 81-8973 (octocog alfa; Kovaltry®) is an unmodified, full-length recombinant factor VIII (FVIII) concentrate with the same amino acid sequence as Kogenate® FS, but produced...” PMID 27577234 ↗ Oct 20168“BAY 81-8973 is a new full-length human recombinant factor VIII product manufactured with technologies to improve consistency in glycosylation and expression to optimize...” PMID 25546368 ↗ Mar 2015 “BAY 81-8973 is a full-length, unmodified, recombinant human factor VIII (FVIII) for the treatment of hemophilia A.” PMID 28005225 ↗ Sep 2017 “BAY 81-8973 (Kovaltry(®) ) is a full-length, unmodified recombinant human factor VIII (FVIII)” PMID 27339736 ↗ Jun 2016 “Recombinant Factor VIII (Kovaltry, BAY81-8973) Treatment Group 1” NCT04565236 ↗ “Biological: Recombinant Factor VIII (Kovaltry, BAY81-8973)” NCT01311648 ↗ |
| Known as | BAY14-2222 | “one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg” NCT01029340 ↗4“BAY94-9027 + Recombinant Factor VIII (Kogenate FS, BAY14-2222)” NCT01184820 ↗ “Kogenate (BAY 14-2222)” NCT00621673 ↗ “Kogenate (BAY14-2222)” NCT00606060 ↗ |
| Known as | FVIII | “Using FVIII (Advate) 50IU/kg.QoD or 100IU/kg.QoD” NCT06864975 ↗ |
| Known as | Helixate FS | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00717626 ↗ |
| Known as | Kogenate | “Kogenate” NCT01051544 ↗ |
| Known as | Kogenate FS | “Recombinant Factor VIII (Kogenate FS, BAY14-2222)” NCT00629837 ↗5“rFVIII-FS (octocog-alfa), (Kogenate FS)” NCT00586521 ↗ |
| Known as | Kovaltry | “BAY 81-8973 (Kovaltry(®) ) is a full-length, unmodified recombinant human factor VIII (FVIII)” PMID 27339736 ↗ Jun 2016 |
| Known as | Octocog alfa | “BAY 81-8973 (octocog alfa; Kovaltry®) is an unmodified, full-length recombinant factor VIII (FVIII) concentrate with the same amino acid sequence as Kogenate® FS, but produced...” PMID 27577234 ↗ Oct 20167“rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 70 IU/kg, dosing by injection once per week” NCT00632814 ↗ “rFVIII-FS (octocog-alfa), (Kogenate FS)” NCT00586521 ↗ |
| Known as | rAHF-PFM | “OBJECTIVE: To evaluate the efficacy and safety of ADVATE rAHF-PFM (Baxter Healthcare Corporation), a recombinant FVIII concentrate manufactured without human or bovine...” PMID 19216617 ↗ Mar 2009 |
| Known as | Recombinant Factor VIII | “Recombinant Factor VIII (Kogenate FS, BAY14-2222)” NCT00629837 ↗ |
| Known as | Recombinate | “Recombinate” NCT01051544 ↗ |
| Known as | rFVIII | “Participants received on-demand treatment with recombinant factor VIII (rFVIII, BAY81-8973) assayed by CS/EP” NCT01233258 ↗ |
| Known as | rFVIII-FS | “rFVIII-FS (octocog-alfa), (Kogenate FS)” NCT00586521 ↗ |
| Action | Restore | “factor VIII replacement” NCT00717626 ↗ |
| Modality | Protein / enzyme biologic | “a recombinant FVIII concentrate” PMID 19216617 ↗ Mar 2009 |
| Route | Intravenous | “one single intravenous (IV) injection of BAY81-8973 50 IU/kg” NCT01029340 ↗ |