valoctocogene roxaparvovec-rvox
Drug Details
- Generic Name
- valoctocogene roxaparvovec-rvox
- Brand Names
- ROCTAVIAN
- Application Number
- BLA125720
- Sponsor
- BioMarin Pharmaceutical Inc.
- NDC Codes
- 2
- Dosage Forms
- INJECTION, SUSPENSION
- Routes
- INTRAVENOUS
- Active Ingredients
- VALOCTOCOGENE ROXAPARVOVEC
Indications and Usage
1 INDICATIONS AND USAGE ROCTAVIAN 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 < 1 IU/dL) without antibodies to adeno-associated virus serotype 5 (AAV5) detected by an FDA-approved test. ROCTAVIAN 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 < 1 IU/dL) without pre-existing antibodies to adeno-associated virus serotype 5 detected by an FDA-approved test. ( 1 )