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Affymax, Inc. (AFFY) Message Board

  • onehewtdoc onehewtdoc Mar 26, 2013 6:23 PM Flag

    Here is my two cents, and i am actually a nephrologist

    Omontys is a ESA, there are others on the market approved for CKD/Hemodialysis.

    1. Omontys is only approved for Hemodialysis patients.
    2. You have Epogen/Aranesp which can be used in both CKD/HD patients. So as it currently stands with FDA approval. Omontys only approved for Hemodialysis patients.
    3. Good thing about Omontys is its once a month dosage. Where as epogen is 3x week with each HD
    4.As far as reactions are concerned, i have not read the new data about hypersensitivity reactions with Omontys. Label already says hypersensitivity reactions are possible. Question is what is the truth. Did Omontys fudge the numbers initially to get approval? or is the new study fudging numbers? How big was the new study? You need to show strength in numbers. Who sponsored the new study?.
    5. Lets says everything with the new study is correct. AFFY needs to look into the root cause, is it a preservative that is causing it? or is it really the drug. Did is only occur in certain subset of patient population?
    6. There is also a issue with bundling in HD patients. Most HD patients are medicare paid. Govt has said that for each HD session, you will get a set amount of $ for each patient. That includes all meds a HD patient is to receive (ESA, Iron, Zemplar) I do not know what the cost of Omontys is. We use epogen at our center.
    7. As a MD for a patient in the US where one is always worried about being sued for something. For now i think most nephrologist will stay away from Omontys based on the publicity it has received. BECAUSE THERE IS AN ALTERNATIVE. SO WHY TAKE THE CHANCE. IF YOU WERE A PATIENT WHICH DRUG WOULD YOU PREFER?
    8. Now i am not saying its all bad news for Omontys. Can they get approval for CKD patients? if so that changes the entire realm of things. How about cancer patients with anemia? Also so what if Omontys is pulled of shelf in the US. There is Europe/ASIA/CANADA physician litigation is completely different as is patient pop.

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