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Fidanacogene elaparvovec - Spark Therapeutics

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Drug Profile

Fidanacogene elaparvovec - Spark Therapeutics

Alternative Names: AAV8 factor IX gene therapy; AAV8 hFIX19; BEQVEZ; DURVEQTIX; Haemophilia B gene therapy - Spark Therapeutics; PF-06838435; rAAV-Spark100-hFIX-Padua; SPK 9001; SPK-FIX

Latest Information Update: 24 Apr 2025

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At a glance

  • Originator The Childrens Hospital of Philadelphia
  • Developer Pfizer
  • Class Antihaemorrhagics; Gene therapies
  • Mechanism of Action Factor IX 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 B
  • New Molecular Entity No

Highest Development Phases

  • Marketed Haemophilia B

Most Recent Events

  • 17 Apr 2025 Efficacy, adverse events and pharmacodynamics data from a phase I/II trial in Haemophilia B released by Pfizer
  • 28 Feb 2025 Pfizer terminates its licensing agreement for Fidanacogene elaparvovec with Spark Therapeutics
  • 04 Sep 2024 Launched for Haemophilia B in USA (IV) prior to September 2024

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