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Proper Name: valoctocogene roxaparvovec-rvox
Tradename: ROCTAVIAN
Manufacturer: BioMarin Pharmaceutical Inc.


  • Indicated for the treatment of adults with severe hemophilia A (congenital factor VIII deficiency with factor VIII activity <1 IU/dL) without pre-existing antibodies to adeno-associated virus serotype 5 detected by an FDA-approved test.

Production Information

  • Package Insert - ROCTAVIAN
  • Demographic Subgroup Information – valoctocogene roxaparvovec-rvox (ROCTAVIAN)
    Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.

Supporting Documents

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