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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: 13 May 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

  • 09 May 2024 Roche announces intention to submit regulatory application for Duchenne muscular dystrophy (In children, In infants, In neonates) in or after 2027 (Roche pipeline, May 2024)
  • 08 Mar 2024 Sarepta Therapeutics suspends phase I trial in Duchenne muscular dystrophy (In children, In infants) in Spain (NCT06241950, EudraCT2022-003407-15)
  • 16 Feb 2024 The US FDA assigns review goal date of (21/06/2024) for the priority review of efficacy supplement of BLA for delandistrogene moxeparvovec for Duchenne muscular dystrophy
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