Takeda Pharmaceutical Co.
) 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
In Feb 2013, Takeda and its partner
) 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.
Takeda carries a Zacks Rank #4 (Sell). Other companies like
Jazz Pharmaceuticals plc
Salix Pharmaceuticals Ltd.
) look more attractive with a Zacks Rank #1 (Strong Buy).
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