Cangene Corp. (CNJ.TO) said Thursday that it has withdrawn the Marketing Authorization Application for hemophilia compound IB1001 in Europe and plans to re-file the MAA with the additional clinical data requested by the European Medicines Agency.
In February, Cangene acquired all rights to the development of the investigational hemophilia compound IB1001 from Ipsen and Inspiration Biopharmaceuticals Inc. IB1001 is being developed for the treatment and prevention of bleeding episodes with hemophilia B. At the time of the acquisition, the asset was under regulatory review by the U.S. Food and Drug Administration and in the latter stages of review by the EMA.
Last month, Cangene presented an Oral Explanation of IB1001 at the Committee for Medicinal Products for Human Use. The EMA subsequently requested additional clinical data for IB1001 as part of the Marketing Authorization Application's Centralised Procedure. Given the results of the clinical study producing the data requested will not be available within the timeframe allowed in the Centralised Procedure,
Cangene said it continues to address the FDA issued Complete Response Letter with a clearly defined path to approval in connection with the Biologics License Application.
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