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  • j.qpublic30 j.qpublic30 Dec 15, 2012 2:53 PM Flag

    eu approval

    I went into the EMA website. I couldn't find krystexxa or Pegloticase listed on the "Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use" website.

    It states
    "This list only includes information for medicines whose applications have been validated at the time the
    report was compiled. The information in this report was compiled on 29 October 2012.
    Information on designated orphan medicines that are being assessed for marketing authorisation is
    also available in the monthly reports of the Committee for Orphan Medicinal Products (COMP).
    Information in bold corresponds to new entries in the monthly list.
    Entries are removed from this list once the medicine has received a positive or negative opinion from
    the CHMP or when the applicant has withdrawn the application. The Agency publishes information on
    these opinions and withdrawn applications on its website.

    Information on CHMP opinions is also published in the monthly CHMP highlights.

    I could not find either krystexxa or pegloticase on the list. has anyone else gone to the EMA website and found either name on the list for drugs under evaluation? I did find where krystexxa had a POSIVE opinion filed on 18/10/2012 but that is it. Anyone else see what I'm talking anout?

    I'm hoping a decision was made and we should know soon!

    Sentiment: Strong Buy

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    • The EMA does not approve/grant marketing authorisation. The European Commission does.

      The EMA is an agency that evaluates drugs for the European Commission. They do this through scientific committees. The CHMP is the scientific committee that does scientific research for drugs for human use. The CHMP opinion is the EMA opinion. That is given to the EU Commission who decides whether to approve marketing authorisation.

    • The CHMP recommendation was issued as their site indicates. The next step is EMA Marketing Authorization which should occur on or about December 24th. I don't believe that the CHMP site will have any further information on this matter.

      Sentiment: Buy

      • 2 Replies to mikerconfer
      • I understand what you are saying. BUT, what I'm saying is, the drug (pegloticase) does not appear on the list "Applications for new human medicines under evaluation
        by the Committee for Medicinal Products for Human Use"

        Drugs that are approved or denied are removed from the list. Is it possible that a decision HAS been made, and we'll be hearing something very soon.

        Or was pegloticase never on this list.

        Sentiment: Strong Buy