TheraRadar
Data updated: May 26, 2026

ADUHELM (aducanumab-avwa)

First-in-Class Priority Review Accelerated Approval Fast Track
CNS Approved 2021-06-07
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
1
Priority Reviews
4
Years on Market

Details

Status
Prescription
First Approved
2021-06-07
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Biogen
Active Ingredient: ADUCANUMAB-AVWA

ADUHELM Approval History

2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
12 FDA actions from 2021 to 2024 · 1 indication expansions
Mar 2024 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter
Aug 2023 SUPPL
Label · Labeling
FDA Letter Label
Feb 2023 SUPPL
Efficacy
FDA Letter Label

What ADUHELM Treats

2 FDA approvals

Originally approved for its first indication in 2021 . Covers 2 distinct patient populations.

  • Other (2)
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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.

ADUHELM FDA Label Details

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Data Sources

FDA Approval: BLA761178 → Trials: ClinicalTrials.gov →

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