Abbott Labs pulls its MMA and BLA for psoriasis drug Ozespa

The European Medicines Agency says it has been formally notified by US Health care major Abbott Laboratories (NYSE: ABT) of its decision to withdraw its application for a centralized marketing authorization for Ozespa (briakinumab), 100mg solution for injection. The drug’s Biological License Application has also been withdrawn in the USA, Abbott said in a separate US Securities and Exchange Commission filing.

This drug 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 application for the marketing authorization for Ozespa was submitted to the Agency on September 2, 2010. At the time of the withdrawal it was under review by the EMA's Committee for Medicinal Products for Human Use (CHMP).

In its official letter, Abbott 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 timeframe allowed in the centralized procedure.