AAV-hAADC gene therapy - Voyager Therapeutics

Drug Profile

AAV-hAADC gene therapy - Voyager Therapeutics

Alternative Names: AAV-AADC; AAV-AADC gene therapy; AAV-AADC gene therapy - Voyager Therapeutics; AAV-hAADC-2; AAV2-hAADC; AV201; GZ 404477; VY AADC01; VY-AADC; VY-AADC02

Latest Information Update: 25 Jun 2018

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At a glance

  • Originator University of California at San Francisco
  • Developer National Institutes of Health (USA); Sanofi Genzyme; University of California at San Francisco; Voyager Therapeutics
  • Class Antiparkinsonians; Gene therapies
  • Mechanism of Action Dopamine release stimulants; Gene transference
  • Orphan Drug Status

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

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase I Parkinson's disease

Most Recent Events

  • 21 Jun 2018 AAV-hAADC receives Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for the treatment of Parkinson’s disease
  • 14 Mar 2018 Voyager Therapeutics anticipates approval of IRB submissions for activation of multiple sites in a phase II/III programme for advanced Parkinson’s disease and intends to complete a Type C meeting with the Office of Tissues and Advanced Therapies division of the FDA’s Center for Biologics Evaluation and Research to incorporate the feedback into the trial in the middle of 2018
  • 09 Mar 2018 Voyager Therapeutics intends to conduct Type C meeting with US FDA for discussions related to data from a phase Ib trial and the design of a planned phase II/III trial in Parkinson's disease
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