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Abbott Withdraws MAA for Ozespa

Abbott Laboratories has withdrawn its centralized marketing authorization application with Europe’s EMA for Ozespa, briakinumab, 100 mg solution for injection, for the treatment of moderate to severe chronic plaque psoriasis in adults who failed to

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Abbott Laboratories has withdrawn its centralized marketing authorization application with Europe’s EMA for Ozespa, briakinumab, 100 mg solution for injection, for the treatment of moderate to severe chronic plaque psoriasis in adults who failed to respond to, or who are intolerant to other systemic therapies.

At the time of the withdrawal it was under review by the agency’s Committee for Medicinal Products for Human Use (CHMP). According to a company statement, the decision was based on the views from day 80 assessment reports that additional new data and analyses would be required for a favorable opinion, which could not be generated within the timeframe allowed in the centralized procedure.

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