Roctavian (valoctocogene roxaparvovec-rvox)

BL 125720

Roctavian (valoctocogene roxaparvovec-rvox)

BL 125720

U.S. License Holder:

BioMarin Pharmaceutical Inc.

Date of License:

June-29-2023

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

ROCTAVIAN (valoctocogene roxaparvovec-rvox) is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with severe hemophilia A (congenital factor VIII deficiency with factor VIII activity less than 1 IU/dL) without pre-existing antibodies to adeno-associated virus serotype 5 detected by an FDA-approved test.

Methodology

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