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Omaveloxolone - Biogen

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Drug Profile

Omaveloxolone - Biogen

Alternative Names: ABT-RTA-408; RTA-408; SKYCLARYS

Latest Information Update: 14 Feb 2024

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At a glance

  • Originator Dartmouth College; University of Texas M. D. Anderson Cancer Center
  • Developer Biogen
  • Class Analgesics; Anti-inflammatories; Antineoplastics; Eye disorder therapies; Neuroprotectants; Small molecules; Triterpenes
  • Mechanism of Action NF E2 related factor 2 stimulants
  • Orphan Drug Status

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

    Yes - Malignant melanoma; Friedreich's ataxia
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Friedreich's ataxia
  • Phase II Mitochondrial disorders; Ocular inflammation; Ocular pain
  • Phase I/II Malignant melanoma
  • Preclinical Brain disorders
  • Discontinued Duchenne muscular dystrophy; Non-small cell lung cancer; Radiation-induced skin damage

Most Recent Events

  • 12 Feb 2024 Registered for Friedreich's ataxia (In adolescents, In adults) in European Union (PO)
  • 15 Dec 2023 Biogen expects final decision from European Commission on marketing authorization for omaveloxolone in the first quarter of 2024
  • 15 Dec 2023 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issues positive opinion for omaveloxolone in Friedreich’s ataxia
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