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Affymax, Inc. (AFFY) Message Board

  • maxdad01 maxdad01 Jul 17, 2013 4:05 PM Flag

    AMAG as REFERENCE POINT TO AFFYMAX...Yes, potential competition BUT

    do NOT know dosage regimen (AFFY's definitive advantage over other ESA's)...Read the article below and ask yourself how would Omontys NOT be put back on the market.

    Anyway, here's the text on AMAG:

    LEXINGTON, Mass.—AMAG Pharmaceuticals announced June 21 that it has updated the product label for Feraheme (ferumoxytol) Injection for Intravenous (IV) use.

    This update is based on the U.S. Food and Drug Administration's (FDA) approval of the company's Label Supplement submission, which included additional post-marketing safety data. Feraheme is indicated for the treatment of iron deficiency anemia in adult chronic kidney disease (CKD) patients.

    The updated product label, also called a package insert includes, among other things: Modifications to the Contraindications section removing "evidence of iron overload" and "anemia not caused by iron deficiency" and modifications to the Hypersensitivity Reactions language of the Warnings and Precautions section to include:

    The following revised text: "serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Feraheme," and
    A decrease in the observation period to monitor patients for signs and symptoms of hypersensitivity during and following Feraheme administration from 60 minutes to 30 minutes.

    "We are pleased that the post-marketing safety data support reverting back to a 30-minute monitoring period following Feraheme administration," said Brian J.G. Pereira, MD, president and CEO of AMAG. "The dosing schedule of Feraheme allows for a full course of IV iron to be delivered in two doses, just three to eight days apart. This dosing schedule, combined with the revised observation period, supports the differentiation of Feraheme in the marketplace."

 
AFFY
0.0914+0.0004(+0.44%)Nov 26 3:50 PMEST

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