Product Description
Aducanumab (Aduhelm™) has received accelerated approval as a treatment for Alzheimer's disease from the U.S. Food and Drug Administration (FDA). This is the first FDA-approved therapy to address the underlying biology of Alzheimer's disease. It is the first therapy to demonstrate that removing beta-amyloid, one of the hallmarks of Alzheimer's disease, from the brain is reasonably likely to reduce cognitive and functional decline in people living with early Alzheimer's. (Sourced from: https://www.alz.org/alzheimers-dementia/treatments/aducanumab)
Mechanisms of Action: AB Antagonist
Novel Mechanism: No
Modality: Antibody
Route of Administration: Intramuscular, Intravenous, Oral, Topical
FDA Designation: Accelerated Approval - Alzheimer Disease *
Approval Status: Approved
Approved Countries: Brazil | Dominican Republic | Italy | United Arab Emirates | United States | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Neurimmune
Company Location:
Company CEO:
Additional Commercial Interests: Biogen
Clinical Description
Countries in Clinic: Australia, Belgium, Brazil, Canada, Finland, France, Germany, Italy, Japan, Mexico, Poland, Portugal, South Korea, Spain, Sweden, Switzerland, United Kingdom, United States
Active Clinical Trial Count: 3
Recent & Upcoming Milestones
- FDA extended pdufa date for aducanumab to June 7, 2021, may be approved in summer 2021, impacting PMN310 development positively.
- Aducanumab's PDUFA date is on March 7, 2021, for potential approval as the first Alzheimer's disease-modifying treatment.
Highest Development Phases
Phase 3: Alzheimer Disease
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| jRCT2021220027 | P3 |
Recruiting |
Alzheimer Disease |
2027-05-31 |
|||
| JapicCTI-205281 | P3 |
Planned |
Alzheimer Disease |
2023-08-31 |
|||
| 2019-004368-22 | P3 |
Completed |
Alzheimer Disease |
2024-07-04 |
55% |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
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