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Affymax, Inc. Message Board

  • godwinpeak godwinpeak Jun 28, 2013 10:51 AM Flag

    CHMP's Concerns Regarding Omontys

    What was the recommendation of the CHMP at that time?

    Based on the review of the data and the company’s responses to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Omontys could not have been approved. In particular, the CHMP was concerned by some supportive study results indicating that Omontys may increase the risk of death or heart and circulatory problems in patients treated for the first time compared with similar medicines for stimulating red blood cell production. The Committee was also concerned by the results of inspections indicating that the study data submitted might not be fully reliable. In addition, the CHMP was concerned by reports of serious hypersensitivity (allergic) reactions, including fatal reactions, in some patients given Omontys in the United States, which had led to the removal of Omontys from the US market in February 2013. Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Omontys did not outweigh its risks.

    It is significant that the CHMP questioned the study data suggesting it "might not be fully reliable". I had earlies posted the huge differences in the patient safety profile between the US based EMERALD studies and European based PEARL studies. EMERALD found O was as just as safe as Epogen when administered to CKD patients on dialysis. PEARL found O to be unsafe compared to Epogen when administered to the healthier CKD patients not on dialysis. AFFY said the differences in patient safety profile was "inexplicable" and one for which "there is no definitive answer." Looks like the CHMP was not fooled like the FDA.

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