Takeda Pharmaceutical Co. (TKPYY) recently withdrew its Marketing Authorization Application (MAA) for Omontys in Europe. The European Medicines Agency (:EMA) had accepted the MAA for the treatment of anemia due to chronic kidney disease (:CKD) in adult patients on dialysis in Feb 2012.
In Feb 2013, Takeda and its partner Affymax, Inc. (AFFY) had announced that they have recalled all lots of Omontys voluntarily in the US. The recall was prompted by data from post-marketing studies which revealed that fatal reactions including anaphylaxis were found to be associated with the use of Omontys. The decision was in conformity with the US Food and Drug Administration’s (:FDA) views.
A letter to heath care professionals was also issued stating that no patients (new or existing) should be on Omontys. We remind investors that Omontys received approval in the US, in Mar 2012, for the treatment of anemia due to CKD in adult patients on dialysis. The product received approval on the basis of randomized, controlled, open-label, phase III EMERALD studies (EMERALD 1 and 2) which evaluated Omontys in 2,606 patients.
However, data from post-marketing studies revealed that hypersensitivity reactions were observed in approximately 0.2% of the patients receiving Omontys and approximately one-third of these patients experienced severe reactions, necessitating immediate medical care and even hospitalization.
Takeda is investigating the cause of these hypersensitivity reactions. The decision to withdraw the MAA was taken because investigations into the adverse reactions will not be completed during the stipulated regulatory procedure.
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