drugset
Drugs / Recombinant Factor VIII
last change Mar 2018 re-read 3 minutes ago

Recombinant Factor VIII

also known as BAY14-2222 · Kogenate FS · Advate · Helixate FS · KoegenateFS · Rec. factor VIII · rFVIII

Protein / enzyme biologic

Developed for
hemophilia A · severe hemophilia A · hereditary von Willebrand disease
Investigated by
Bayer · Baxalta now part of Shire · Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Octapharma · The Hospital for Sick Children

Trials 7

today NCT02930317 · Ph 3 NCT01810666 · Ph 4 NCT01653639 · Ph 1 NCT01410227 · Ph 3 NCT01125813 · Ph 3 NCT00623480 · Ph 3 NCT01085344 · Ph 4
1997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT01653639 Jul → Dec 2012 hemophilia A Bayer Completed No outcome recorded
Phase 34 trials · 2 met primary
Phase 3 NCT02930317 Aug 2016 → Oct 2017 hemophilia A Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Unknown No outcome recorded
Phase 3 NCT01410227 Nov 2011 → Feb 2014 hereditary von Willebrand disease Baxalta now part of Shire Completed Met primary
Phase 3 NCT01125813 Jun 2010 → Jan 2012 severe hemophilia A Octapharma Completed No outcome recorded
Phase 3 NCT00623480 Mar 2008 → Sep 2011 hemophilia A Bayer Completed Met primary
Phase 42 trials
Phase 4 NCT01810666 Mar 2013 → Jan 2014 hemophilia A Bayer Completed No outcome recorded
Phase 4 NCT01085344 Jun 1997 → Dec 2012 severe hemophilia A The Hospital for Sick Children Completed No outcome recorded

Press releases naming this drug 14 releases

DateIssuerRelease
2018-03-05 Takeda Shire launches myPKFiT™ for ADVATE® [Antihemophilic Factor (Recombinant)] in the U.S. takeda.com ↗
2017-12-19 Takeda Shire receives FDA clearance for myPKFiT™ for Advate® [Antihemophilic Factor (Recombinant)] to help personalize care for hemophilia A takeda.com ↗
2015-04-16 Nektar Therapeutics Baxter Submits Application To Japan's MHLW For Approval Of BAX 855, Extended Half-Life Recombinant FVIII Based On ADVATE For Hemophilia A nektar.com ↗
2015-02-11 Nektar Therapeutics Baxter Presents Additional Data From Pivotal Study Of BAX 855, Extended Half-life Investigational Recombinant FVIII Based On ADVATE For Hemophilia A nektar.com ↗
2014-12-01 Nektar Therapeutics Baxter Submits Application For US FDA Approval Of BAX 855, Extended Half-Life Recombinant FVIII Based On ADVATE For Hemophilia A nektar.com ↗
2014-05-01 CSL Behring CSL Behring Enrolls First Patient in Global Pediatric Phase III Pivotal Study of Recombinant Factor VIII Single Chain (rVIII-SingleChain) to Treat Severe Hemophilia A csl.com ↗
2012-10-31 Sobi, Inc. BIOGEN IDEC AND SOBI ANNOUNCE POSITIVE TOP-LINE RESULTS FROM PHASE 3 STUDY INVESTIGATING LONG-LASTING RECOMBINANT FACTOR VIII FC FUSION PROTEIN IN HEMOPHILIA A sobi.com ↗
2012-10-31 Biogen Biogen Idec and Sobi Announce Positive Top-Line Results from Phase 3 Study Investigating Long-Lasting Recombinant Factor VIII Fc Fusion Protein in Hemophilia A biogen.com ↗
2011-07-26 Sobi, Inc. BIOGEN IDEC AND SWEDISH ORPHAN BIOVITRUM PRESENT DATA ON LONG-LASTING RECOMBINANT FACTOR VIII THERAPY AT INTERNATIONAL SOCIETY ON THROMBOSIS AND HAEMOSTASIS MEETING sobi.com ↗
2011-07-26 Biogen Biogen Idec and Swedish Orphan Biovitrum Present Data on Long-Lasting Recombinant Factor VIII Therapy at International Society on Thrombosis and Haemostasis Meeting biogen.com ↗
2010-12-06 Sobi, Inc. Biogen Idec and Swedish Orphan Biovitrum Announce First Patient Dosed in Global Registrational Trial of Long-Lasting Recombinant Factor VIII Fc Fusion Protein sobi.com ↗
2010-12-06 Biogen Biogen Idec and Swedish Orphan Biovitrum Announce First Patient Dosed in Global Registrational Trial of Long-Lasting Recombinant Factor VIII Fc Fusion Protein biogen.com ↗

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 7 sources stand behind the page.

FieldValueCited text
Known as Recombinant Factor VIII ClinicalTrials.gov intervention name — accepted as the source's own label NCT01653639 ↗
6

NCT00623480 ↗

NCT02930317 ↗

NCT01125813 ↗

NCT01810666 ↗

NCT01085344 ↗

NCT01410227 ↗
Known as Advate “Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS)” NCT01085344 ↗
Known as BAY14-2222 “Recombinant Factor VIII (Kogenate FS, BAY14-2222)” NCT00623480 ↗
2

“Recombinant Factor VIII (Kogenate FS, BAY14-2222)” NCT01653639 ↗

“Recombinant Factor VIII (Kogenate FS, BAY14-2222)” NCT01810666 ↗
Known as Helixate FS “Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS)” NCT01085344 ↗
Known as KoegenateFS “Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS)” NCT01085344 ↗
Known as Kogenate FS “Recombinant Factor VIII (Kogenate FS, BAY14-2222)” NCT01653639 ↗
2

“Recombinant Factor VIII (Kogenate FS, BAY14-2222)” NCT01810666 ↗

“Recombinant Factor VIII (Kogenate FS, BAY14-2222)” NCT00623480 ↗
Known as Rec. factor VIII “Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase.” NCT01810666 ↗
Known as rFVIII “rFVIII” NCT01410227 ↗
Action Restore “Escalating Dose Prophylactic factor replacement” NCT01085344 ↗
Modality Protein / enzyme biologic “Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)” NCT00623480 ↗
Route Intravenous “intravenously (IV)” NCT00623480 ↗