Drug Profile

Valoctocogene roxaparvovec companion diagnostic - ARUP Laboratories/BioMarin

Alternative Names: AAV5 DetectCDx; AAV5 TAb Assay; AAV5 total antibody assay - ARUP Laboratories/BioMarin

Latest Information Update: 03 Jul 2023

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At a glance

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity No

29 Jun 2023 Registered for Haemophilia A (Diagnosis) in USA (unspecified route)
22 Apr 2022 Valoctocogene roxaparvovec companion diagnostic is still in preregistration for Haemophilia A (Diagnosis) in USA
20 Feb 2020 Preregistration for Haemophilia A (Diagnosis) in USA (unspecified route)

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