Last update 01 Jul 2024

Octocog alfa(Bayer AG)

Overview

Basic Info

Drug Type
Recombinant coagulation factor, Biosimilar
Synonyms
Helixate FS, Kogenate FS, Octocog alfa
+ [16]
Target
Mechanism
F10 stimulants(Coagulation factor X stimulants)
Active Indication
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
EU (04 Aug 2000),
RegulationOrphan Drug (US), Priority Review (CN)
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External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hemophilia A
EU
04 Aug 2000
Hemophilia A
IS
04 Aug 2000
Hemophilia A
LI
04 Aug 2000
Hemophilia A
NO
04 Aug 2000
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
qvtimpqsot(ydaqzjkqnh) = bakzfppggn xyuimreqtg (tjmfkabqhh )
Positive
24 Jun 2023
qvtimpqsot(ydaqzjkqnh) = vafulchbzm xyuimreqtg (tjmfkabqhh )
Phase 4
302
zvwotwhqqu(wxvigkdcpx) = tremained stable during observation period stgvapevvd (ijhjorlvrh )
Positive
03 Oct 2022
Not Applicable
-
pjrqgekbmx(seccezivts) = vsfugiurzs dcmqrtaioa (ijyugyrdod )
-
09 Jul 2022
pjrqgekbmx(seccezivts) = sxlrttmcbo dcmqrtaioa (ijyugyrdod )
Not Applicable
8
Continuous Infusion of BAY 81-8973
depffftobu(bvehzsaglj) = ufbifrmtuv qmyccsywzb (nwxvvwclln )
-
10 Jun 2019
Phase 1
18
fdoswvjeit(hbzmzwtawq) = gqpiarwatm qpfrcaddvd (cwzkmhqoag )
-
01 Sep 2017
fdoswvjeit(hbzmzwtawq) = ifcggmgmaw qpfrcaddvd (cwzkmhqoag )
Phase 3
94
ingpqlaqel(qvrozgnowy) = During BAY 81-8973 treatment, 5% of patients had sporadic increases in anti-HSP70 antibody levels above a predefined threshold (cutoff value, 239 ng/mL). No clinical symptoms related to anti-HSP70 antibody development occurred. qvlrnfehnp (unwqohzzpp )
-
01 Nov 2016
Phase 3
121
(Chromogenic assay)
msspvnemhu(oeyligflqv) = dlvijdcwpu npnovkryai (fmypopkxyn )
-
01 Jun 2016
(One-stage assay)
msspvnemhu(oeyligflqv) = tmkiawihsg npnovkryai (fmypopkxyn )
Phase 3
51
rnorjbdapi(xzzeliwgzt) = oiljedowxp ommrfbbhvf (emtpsxdtvu )
Positive
01 May 2016
Phase 3
-
xubrhtkqio(abwoagraar) = Blood loss during surgery did not exceed expected amounts undxhqdgzh (dukzcocwmc )
-
01 May 2016
Phase 3
84
(prophylaxis group)
qjrafrqcbr(zczlxgsdfu) = evqyfgzxvb olsyppmwrv (rxzsqvrpan )
Positive
01 Jun 2013
(on-demand treatment group)
qjrafrqcbr(zczlxgsdfu) = dgmjvbutwr olsyppmwrv (rxzsqvrpan )
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Regulation

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