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Arena Pharmaceuticals, Inc. Message Board

  • vjkstocks vjkstocks Dec 10, 2013 10:48 PM Flag

    time required for CHMP approval of Celgene's REVLIMID after withdrawal was about a year.

    Belviq's timeline after re-submission could be along the same lines
    . REVLIMID had also to address benefit/risk ratio issues. There could be other parameters that can weigh in the approval of Belviq in EMA but the so called rat cancer issue was thorougly scrutinized by the fda and was deemed not an issue..
    Following is the example of Celgene's REVLIMID.
    BOUDRY, Switzerland--(BUSINESS WIRE)--Jun. 21, 2012-- Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG), is providing a regulatory update for REVLIMID (lenalidomide) and pomalidomide as treatments for multiple myeloma.

    As we responded to each specific set of questions and discussed the progress of the application with our CHMP assessors, the 180-day questions made it clear that the follow-up and maturity of the studies with respect to the potential impact of second primary malignancies [SPMs] on the current survival trends had become a principle concern.
    We have decided to withdraw the new indication submission to the Committee for Medicinal Products for Human Use (CHMP) for REVLIMID (lenalidomide).
    In response to the CHMP’s request, we plan to re-submit with more mature data, which allows CHMP to conclude a clear benefit/risk ratio.

    Revlimid Gets Positive Opinion For Use In MDS From European Advisory Committee
    One Comment By The MDS Beacon Staff
    Published: Apr 29, 2013 2:19 pm
    Revlimid Gets Positive Opinion For Use In MDS From European Advisory Committee

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