NeLM news service
Marketing authorisation application for briakinumab (Ozespa®) withdrawn

Source: EMA

Date published: 17/01/2011 15:51

Summary
by: Nicola Pocock

Abbott Laboratories Limited has withdrawn its application for a centralised marketing authorisation for briakinumab (Ozespa), as the additional new data and analyses thought to be required for a favourable opinion could not be generated within the timeframe allowed in the centralised procedure.  This 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.

 

The withdrawal of the application has no impact on the ongoing clinical trials, and the company will continue to make briakinumab available for patients enrolled in the trials. 

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