Abbott withdraws marketing authorization application for Ozespa

January 20, 2011
Top Quote The European Medicines Agency said Monday it was notified by Abbott Laboratories Limited (ABT) of its decision to withdraw its application for a centralized marketing authorization for the medicine Ozespa, briakinumab, 100 mg solution for injection. End Quote
  • (1888PressRelease) January 20, 2011 - MAIN FACTS:

    * Medicine was intended to be used for the treatment of moderate to severe chronic plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA.
    * At the time of the withdrawal it was under review by the agency's Committee for Medicinal Products for Human Use, or CHMP.
    * Company stated that its decision to withdraw the application was based on the views of the rapporteurs in their day 80 assessment reports that additional new data and analyses would be required for a favorable opinion, but those could not be generated within the time frame allowed in the centralized procedure.
    * By Tapan Panchal, Dow Jones Newswires. Tel +44(0)207-842 9448, tapan.panchal ( @ ) dowjones dot com

    Copyright © 2011 Dow Jones & Company, Inc. All Rights Reserved

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