Aducanumab

Overview

Aducanumab, or BIIB037, is a monoclonal IgG1 antibody that targets extracellular amyloid-β plaques in the brain; similar to gantenerumab, bapineuzumab and solanezumab. Aducanumab is a recombinant antibody derived from patients with slow or absent cognitive decline, and phase 1b clinical trial data have shown patients treated with aducanumab show a reduction in amyloid-β plaques. Based on Mini-Mental State Examination and Clinical Dementia Rating (CDR), patients taking aducanumab showed signs of slowing progression, however, these data are controversial. Clinical trials showed a 23% relative difference between the experimental and placebo groups as determined by CDR, however, this is equivalent to an absolute difference of 0.4/18. Although aducanumab's approval represents the first drug treatment for Alzheimer's disease, the approval is conditional on further results. Biogen enrolled patients in phase 3 clinical trials in 2015, but increased the size of the trials from 1350 patients to 1650 patients to maintain statistical power in the face of a high standard deviation. Development of aducanumab was discontinued in March 2019 when two phase 3 clinical trials did not pass futility analysis, however, Biogen sought FDA approval in October 2019 after a reanalysis of the data. Aducanumab was granted accelerated FDA approval on 7 June 2021. Continued approval will be based on further trials confirming a clinical benefit over currently available therapy.

Indication

Aducanumab is indicated for the treatment of Alzheimer’s disease. Treatment should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.

Associated Conditions

Alzheimer's Disease (AD)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Safety and Feasibility of Exablate Blood-Brain Barrier Disruption for Mild Cognitive Impairment or Mild Alzheimer's Disease Undergoing Standard of Care Monoclonal Antibody (mAb) Therapy	2022/07/21	NCT05469009	Early Phase 1	Recruiting	Ali Rezai
A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer's Disease	2022/04/04	NCT05310071	Phase 3	Terminated	Biogen
A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)	2021/11/05	NCT05108922	Phase 3	Completed	Eli Lilly and Company
A Study to Assess Absolute Bioavailability of Aducanumab in Healthy Volunteers	2021/06/11	NCT04924140	Phase 1	Completed	Biogen
A Study to Evaluate Safety and Tolerability of Aducanumab in Participants With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205	2020/01/27	NCT04241068	Phase 3	Terminated	Biogen
A Study of Aducanumab in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease Dementia to Evaluate the Safety of Continued Dosing in Participants With Asymptomatic Amyloid-Related Imaging Abnormalities	2018/08/21	NCT03639987	Phase 2	Terminated	Biogen
Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Aducanumab in Healthy Participants	2016/05/26	NCT02782975	Phase 1	Completed	Biogen
221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease	2015/06/29	NCT02484547	Phase 3	Terminated	Biogen
221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease	2015/06/23	NCT02477800	Phase 3	Terminated	Biogen
Single and Multiple Ascending Dose Study of Aducanumab (BIIB037) in Japanese Participants With Alzheimer's Disease	2015/05/05	NCT02434718	Phase 1	Completed	Biogen

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Aduhelm	Biogen Inc.	64406-101	INTRAVENOUS	100 mg in 1 mL	6/8/2021
Aduhelm	Biogen Inc.	64406-102	INTRAVENOUS	100 mg in 1 mL	6/8/2021

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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