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Vaccines, Blood & Biologics

Request for Priority Review Memorandum, February 11,2009 - Anascorp


Date:              February 11, 2009
From:             Hon-Dum Ko, Medical Officer, Clinical Review Branch, DH/OBRR
To:                  File
CC:                 Nisha Jain, Acting Branch Chief, Clinical Review Branch, DH/OBRR
                        Robert Fisher, Chairman of Committee on BLA STN 125335
                        Debbie Cordaro, RPM, DBA/OBRR
Re:                  Request for Priority Review for BLA STN 15335 Anascorp®,
                        Centuroides Immune F(ab’)2 Intravenous (Equine)


In a letter dated January 26, 2009 (received January 27, 2009) Instituto Bioclón S.A. de C.V., applicant of the above BLA, has requests priority review for this application.
The reason offered for this request is:
Instituto Bioclón S.A. de C.V. believes that Anascrop used for the indication of treatment of Scorpion Envenomation, meets an unmet medical need to treat serious and life-threatening condition. There is no other product available to address this medical need and death has occurred due to Scopion Envenomation.
CBER’s policy for priority review, according to SOPP 8405, is:
The product, if approved by CBER or the Center for Drug Evaluation and Research (CDER), would be a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease.
Since there is no U.S. marketed product for the treatment of scorpion envenomation, the approval of the applicant’s product would be a significant improvement in its treatment.
Recommendation: The request for priority review should be approved.

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