Drug Type Recombinant coagulation factor, Biosimilar |
Synonyms Helixate FS, Kogenate FS, Octocog alfa + [16] |
Target |
Mechanism F10 stimulants(Coagulation factor X stimulants) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date EU (04 Aug 2000), |
RegulationOrphan Drug (US), Priority Review (CN) |
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 ) View more | Positive | 03 Oct 2022 | |||
Not Applicable | - | pjrqgekbmx(seccezivts) = vsfugiurzs dcmqrtaioa (ijyugyrdod ) View more | - | 09 Jul 2022 | |||
pjrqgekbmx(seccezivts) = sxlrttmcbo dcmqrtaioa (ijyugyrdod ) View more | |||||||
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 ) View more | - | 01 Sep 2017 | |||
fdoswvjeit(hbzmzwtawq) = ifcggmgmaw qpfrcaddvd (cwzkmhqoag ) View more | |||||||
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 ) View more | Positive | 01 May 2016 | |||
Phase 3 | - | xubrhtkqio(abwoagraar) = Blood loss during surgery did not exceed expected amounts undxhqdgzh (dukzcocwmc ) View more | - | 01 May 2016 | |||
Phase 3 | 84 | (prophylaxis group) | qjrafrqcbr(zczlxgsdfu) = evqyfgzxvb olsyppmwrv (rxzsqvrpan ) View more | Positive | 01 Jun 2013 | ||
(on-demand treatment group) | qjrafrqcbr(zczlxgsdfu) = dgmjvbutwr olsyppmwrv (rxzsqvrpan ) View more |