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An International, Multicentre, Randomised, Evaluator-blind, No-treatment Controlled, Parallel-group Study to Assess the Efficacy and Safety of Once Daily Nitisinone in Patients With Alkaptonuria After 12 Months of Treatment, Followed by an Additional 36 Month Treatment Period.

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An International, Multicentre, Randomised, Evaluator-blind, No-treatment Controlled, Parallel-group Study to Assess the Efficacy and Safety of Once Daily Nitisinone in Patients With Alkaptonuria After 12 Months of Treatment, Followed by an Additional 36 Month Treatment Period.

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 04 Nov 2021

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At a glance

  • Drugs Nitisinone (Primary)
  • Indications Alkaptonuria
  • Focus Therapeutic Use
  • Acronyms SONIA2

    • Most Recent Events

    • 18 Sep 2020 Results published in the Swedish Orphan Biovitrum Media Release
    • 18 Sep 2020 According to a Swedish Orphan Biovitrum media release, The study was recently published in the Lancet Diabetes and Endocrinology.
    • 18 Sep 2020 According to a Swedish Orphan Biovitrum media release, based on the scientific results of the DevelopAKUre clinical development programme, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Orfadin (nitisinone) for the treatment of adult patients with alkaptonuria, the first described human genetic disease. The opinion is now referred to the European Commission for a decision.

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