Affymax, Inc. (AFFY) and its partner Takeda Pharmaceutical Company Limited (TKPYY) recently announced that they have recalled all lots of Omontys (peginesatide) voluntarily. 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 is 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 chronic kidney disease (: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. At that time, the company reported that the most common side effects associated with Omontys were shortness of breath, diarrhea, nausea, cough and arteriovenous fistula site complication.
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.
The companies noted that approximately 0.02% of patients experienced fatal reactions, till date, after administration of intravenous Omontys. Affymax and Takeda are examining the data. We note that the investors have reacted negatively to the news.
Affymax currently carries a Zacks Rank #4 (Sell), while Takeda Pharma carries a Zacks Rank #3 (Hold). Lannett Company, Inc. (LCI) and Cytokinetics, Incorporated (CYTK) look more attractive in the pharma sector. Both carry a Zacks Rank #1 (Strong Buy).
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