Last update 01 Nov 2024

Giroctocogene fitelparvovec

Overview

Basic Info

Drug Type
AAV based gene therapy
Synonyms
AAV Factor 8 cDNA gene therapy, AAV Factor 8 cDNA in vivo gene therapy, AAV cDNA gene therapy
+ [7]
Target
Mechanism
Factor VIII gene transference
Active Indication
Inactive Indication-
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationFast Track (US), Orphan Drug (EU), Regenerative Medicine Advanced Therapy (US)
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External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hemophilia APhase 3
JP
18 Aug 2020
Hemophilia APhase 3
TW
18 Aug 2020
Hemophilia APhase 3
SE
18 Aug 2020
Hemophilia APhase 3
TR
18 Aug 2020
Hemophilia APhase 3
DE
18 Aug 2020
Hemophilia APhase 3
ES
18 Aug 2020
Hemophilia APhase 3
GR
18 Aug 2020
Hemophilia APhase 3
GB
18 Aug 2020
Hemophilia APhase 3
US
18 Aug 2020
Hemophilia APhase 3
SA
18 Aug 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
75
(tkvmsnuxfe) = The AFFINE study achieved its primary objective of non-inferiority, as well as superiority, of total annualized bleeding rate (ABR) from Week 12 through at least 15 months of follow up post-infusion compared with routine Factor VIII (FVIII) replacement prophylaxis treatment. ixcxjgqoiy (hwintxrakm )
Met
Positive
24 Jul 2024
Phase 2
11
(cuqxfiummy) = ywizukgzxe dgwjzkewkz (zdufaqpozi )
Positive
05 Nov 2021
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Deal

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Core Patent

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Clinical Trial

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Approval

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Regulation

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