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Delandistrogene moxeparvovec - Roche/Sarepta Therapeutics

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Drug Profile

Delandistrogene moxeparvovec - Roche/Sarepta Therapeutics

Alternative Names: Delandistrogene moxeparvovec-rokl; Delandistrogenum moxeparvovecum - Roche/Sarepta Therapeutics; ELEVIDYS; rAAVrh74.MHCK7.micro-dystrophin; RG 6356; RO-7494222; SRP-9001

Latest Information Update: 11 Nov 2024

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At a glance

  • Originator Nationwide Children's Hospital
  • Developer Nationwide Children's Hospital; Roche; Sarepta Therapeutics
  • Class Gene therapies; Morpholines
  • Mechanism of Action Dystrophin replacements; Gene transference
  • Orphan Drug Status

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

    Yes - Duchenne muscular dystrophy
  • New Molecular Entity No

Highest Development Phases

  • Marketed Duchenne muscular dystrophy

Most Recent Events

  • 06 Nov 2024 Efficacy and adverse events data from the phase III EMBARK trial in Duchenne muscular dystrophy released by Sarepta Therapeutics
  • 06 Nov 2024 Updated efficacy data from the phase I/II trial in Duchenne muscular dystrophy released by Sarepta Therapeutics
  • 25 Oct 2024 Sarepta Therapeutics completes a phase III trial in Duchenne muscular dystrophy (In children) in US, Belgium, France, Hong Kong, Italy, Spain, Taiwan, Japan the United Kingdom and Germany (IV) (NCT05096221) (EudraCT2019-003374-91)

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