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Exelixis, Inc. Message Board

  • enabeler enabeler Dec 18, 2012 9:41 AM Flag

    EMA accepts Cometriq review

    Exelixis announces EMA acceptance of MAA for COMETRIQ
    Comtex News Network
    Dec 18, 2012 (Datamonitor via COMTEX) -- Exelixis, Inc. has announced that the European Medicines Agency, or EMA, has accepted for review the marketing authorization application, or MAA, for COMETRIQ for the proposed indication of treatment of progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer, or MTC.
    The completion of the MAA validation process confirms that the submission is sufficient to permit a substantive review for marketing authorization in the European Union.
    The MAA contains data from EXAM, the Phase III pivotal study of COMETRIQ in progressive, metastatic MTC. This trial also served as the basis for Exelixis' New Drug Application with the FDA. The FDA approved COMETRIQ for the treatment of progressive, metastatic MTC in November 2012. COMETRIQ received orphan drug designation in the European Union from the Committee for Orphan Medicinal Products (COMP) for the treatment of MTC.
    COMETRIQ inhibits the activity of tyrosine kinases including RET, MET and VEGFR2. These receptor tyrosine kinases are involved in both normal cellular function and in pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, and maintenance of the tumor microenvironment.

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    • Charles Butler tolds me that process will take a year.

    • Any idea on the timeframe for the review? I know that it has been less than two weeks since the FDA decision, but am wondering why the two applications were not done in parallel instead of in series as this PR indicates?

      Hoping that when they give us the thumbs up that the price doesn't capitulate another 10% further.

      Waiting to see what the options expiration effects are on this one as well as the wash rules buy back in 2013, as well as the results from other on going trials. I see 2013 as the start of the push of the price north from here.


      Sentiment: Strong Buy

      • 1 Reply to otherottawaguy
      • "QMI AGENCY

        The US is faster than Canada and Europe at approving new drugs for market, a new study says.

        The Yale University School of Medicine researchers reviewed drug approval decisions by the Food and Drug Administration, Health Canada, and the European Medicines Agency between 2001 and 2010.

        They found the median total time to review was 322 days at FDA, 366 days at EMA and 393 days at Health Canada.

        The FDA was faster even though it reviewed more applications: 225, compared to 186 by the EMA and 99 by Health Canada.

        Among drugs that were approved by all three regulators, "the FDA's reviews were over three months faster," said Nicholas Downing, second-year medical student at Yale and leader of the study.

        And among drugs approved in two markets, the U.S. more often approved them first: 64% of those approved in the States and Europe, and 86% of those approved in the States and Canada."

        But note the above are averages and many countries have fast track processes for some drugs.

        Sentiment: Strong Buy

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