TheraRadar
Data updated: May 26, 2026

Roctavian (valoctocogene roxaparvovec-rvox)

Approved 2023-06-28
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
2
Years on Market

Details

Status
Prescription
First Approved
2023-06-28
Patent Cliff
2030

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Patent cliff and revenue data

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Routes
Intravenous
Dosage Forms
Injection

Companies

Biomarin Pharmaceutical Inc.
Active Ingredient: valoctocogene roxaparvovec-rvox

Roctavian Approval History

2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2023 to 2023
Jun 2023 ORIGINAL
Update · CBER biologic (Purple Book)

What Roctavian Treats

1 FDA approvals

Originally approved for its first indication in 2023 .

  • Other (1)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

Roctavian FDA Label Details

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Data Sources

FDA Approval: BLA125720 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.