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Giroctocogene fitelparvovec - Pfizer

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Drug Profile

Giroctocogene fitelparvovec - Pfizer

Alternative Names: AAV cDNA gene therapy - Sangamo Therapeutics; AAV cDNA hF8 gene therapy; AAV cDNA human Factor 8 gene therapy; AAV Factor 8 cDNA gene therapy; AAV Factor 8 cDNA in vivo gene therapy; PF 07055480; Recombinant AAV2/6 human Factor 8 gene therapy - Sangamo Therapeutics; Recombinant AAV2/6 human Factor VIII gene therapy - Sangamo Therapeutics; SB-525; SB-525 cDNA gene therapy

Latest Information Update: 28 Jul 2024

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At a glance

  • Originator Sangamo BioSciences
  • Developer Pfizer
  • Class Antihaemorrhagics; Gene therapies
  • Mechanism of Action Factor VIII replacements; Gene transference
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Haemophilia A
  • New Molecular Entity No

Highest Development Phases

  • Phase III Haemophilia A

Most Recent Events

  • 24 Jul 2024 Efficacy and adverse event data from a phase III trial in Haemophilia A released by Sangamo Therapeutics
  • 16 Jul 2024 Pfizer completes a phase I/II trial in Haemophilia A in USA (IV) (NCT03061201)
  • 13 Mar 2024 Sangamo Therapeutics and Pfizer announces intention to submit MAA for haemophilia A (IV) in early 2025

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