Kyndrisa: Withdrawal of the marketing authorisation application



On 31 May 2016, BioMarin International Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Kyndrisa, for the treatment of Duchenne muscular dystrophy.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Kyndrisa (drisapersen) (PDF/75.84 KB)

    First published: 24/06/2016
    Last updated: 30/06/2016
    EMA/430531/2016 Rev. 1

  • Key facts

    Product number
    International non-proprietary name (INN) or common name
    • drisapersen
    Active substance
    • drisapersen sodium
    Date of withdrawal
    Company making the application
    BioMarin International Limited
    Withdrawal type
    Initial authorisation

    All documents

    Related information on withdrawals

    A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter (withdrawal letter Doc. type, leave the 'Author' in properties blank).

    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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