Last update 20 Mar 2025

Coagulation factor VIIa (recombinant)-jncw(LFB Biotechnologies SASU)

Overview

Basic Info

Drug Type
Recombinant coagulation factor
Synonyms
EPTACOG BETA ACTIVATED, Recombinant factor VIIa, eptacog beta
+ [6]
Action
inhibitors
Mechanism
tissue factor inhibitors(Tissue factor inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (01 Apr 2020),
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Intraoperative blood loss
Norway
15 Jul 2022
Intraoperative blood loss
European Union
15 Jul 2022
Intraoperative blood loss
Liechtenstein
15 Jul 2022
Intraoperative blood loss
Iceland
15 Jul 2022
Hemophilia A
Mexico
02 Jun 2022
Hemophilia B
Mexico
02 Jun 2022
Hemophilia
United States
01 Apr 2020
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hemophilia ANDA/BLA
European Union
25 Jul 2022
Hemophilia BNDA/BLA
European Union
25 Jul 2022
HemorrhagePhase 3
United States
25 Aug 2016
HemorrhagePhase 3
South Africa
25 Aug 2016
HemorrhagePhase 3
Mexico
25 Aug 2016
HemorrhageDiscovery
Russia
25 Aug 2016
HemorrhageDiscovery
Ukraine
25 Aug 2016
HemorrhageDiscovery
Spain
25 Aug 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
12
(MInor procedure)
smodwuoeyn(bmgplerjnb) = kycciplbcd lzbczjqabx (adcjxsvbvp, 48 - 100)
Positive
05 Nov 2020
(Major procedure)
smodwuoeyn(bmgplerjnb) = meeawmilxh lzbczjqabx (adcjxsvbvp, 23 - 96)
Phase 3
25
(Coagulation Factor VIIa (Recombinant): 75 µg/kg)
kuvdferppl(wimfjppajf) = rqpysrvpdo jjwddikari (filedxxcxy, uhchpqvjid - xpmynxbgyu)
-
28 Aug 2020
(Coagulation Factor VIIa (Recombinant): 225 µg/kg)
kuvdferppl(wimfjppajf) = qywuydyybv jjwddikari (filedxxcxy, nhnaeqygdu - dioqzdlfly)
Phase 3
12
(Major Surgery (LR769 Initial Dose 200 μg/kg; Then 75 μg/kg))
ajgxdogsvu(okxdplcuex) = nkqutrdzmo clifvojnie (rtzmkvytqu, qdeyozifrn - saoaurqllw)
-
06 Sep 2019
(Minor Surgery (LR769 Initial Dose 75 μg/kg; Then 75 μg/kg))
ajgxdogsvu(okxdplcuex) = perjasfagu clifvojnie (rtzmkvytqu, dtqpdiuxtl - tmidnpwvfq)
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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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