Last update 20 Mar 2025

Anti-Inhibitor Coagulant Complex (Baxalta US)

Overview

Basic Info

Drug Type
Blood components
Synonyms
Autoplex, Feiba Nf, Feiba Vh
Action
modulators
Mechanism
F10 modulators(Coagulation factor X modulators), factor IX modulators(Coagulation factor IX modulators), factor VII modulators(Coagulation factor VII modulators)
+ [2]
Active Indication
Inactive Indication-
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (21 Dec 1979),
Regulation-
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R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Hemophilia A
United States
21 Dec 1979
Hemophilia A
United States
21 Dec 1979
Hemophilia B
United States
21 Dec 1979
Hemophilia B
United States
21 Dec 1979
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hemophilia APhase 3
United States
01 Jan 2014
Hemophilia APhase 3
Brazil
01 Jan 2014
Hemophilia BPhase 3
United States
01 Jan 2014
Hemophilia BPhase 3
Brazil
01 Jan 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
45
(Part 1:FEIBA 85 ± 15 U/kg Regular Volume at 2 U/kg/Min Rate)
tiykfycomh(pxrmpexpiw) = kscljwdaqd ceclwjlbsa (olsolrrzia, bkfplkxgsw - cqukkcdvng)
-
09 Feb 2023
(Part 1:FEIBA 85±15 U/kg 50% Reduced Volume at 2 U/kg/Min Rate)
tiykfycomh(pxrmpexpiw) = powgxbwgrm ceclwjlbsa (olsolrrzia, cpotwrcmfj - zzywzllmtc)
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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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