Aducanumab receives controversial FDA approval
Biogen’s Aduhelm™ (aducanumab) is approved to treat patients with Alzheimer’s diseaseJune 13, 2021
Condition: Alzheimer’s disease
Alzheimer’s is a brain disease that causes problems with memory, thinking and behavior. It’s irreversible and progressive, and the most common cause of dementia among older adults. Alzheimer’s causes a continuous decline that affects a person’s ability to function independently. More than 5.8 million people in the United States are living with Alzheimer’s. Of those, 80% are 75 years and older.¹ On average, a person with Alzheimer’s lives four to eight years after diagnosis, but can live as long as 20 years, depending on other factors.²
Plaques and tangles²
Alzheimer’s is defined by the presence of two abnormal protein deposits in the brain:
- beta amyloid plaques: this kind of plaque deposit builds up in the spaces between cells
- neurofibrillary tangles: these are twisted fibers of another protein that builds up inside cells
It’s been shown that most people develop some plaques and tangles as they age. But people with Alzheimer’s have more, and theirs grow in a particular pattern – starting in areas important for memory and then spreading to other regions.
Scientists do not know exactly what role plaques and tangles play in Alzheimer’s disease. Most experts believe they play a critical role in blocking communication among nerve cells, and disrupting processes that cells need to survive.
It’s the destruction and death of nerve cells that causes memory failure, personality changes, problems carrying out daily activities and the many devastating symptoms of Alzheimer’s disease.
Different programs and services can help support people with Alzheimer’s disease and their caregivers. None of the FDA-approved Alzheimer’s drugs address the underlying pathology of Alzheimer’s. The effects they exert lessen over time as the disease progresses.
- Cholinesterase inhibitors: Aricept® (donepezil), Exelon® (rivastigmine), and Razadyne® (galantamine)
- N-methyl-D-aspartate antagonist: Namenda® (memantine)
- Combinations: Namzaric® (donepezil/memantine)
Aducanumab is a human IgG1 anti-A? (beta amyloid) monoclonal antibody. It selectively targets aggregated forms of beta amyloid. Aducanumab is intended to modify the course of Alzheimer’s by promoting clearance of beta amyloid from the brain. If approved, it would be the first disease-modifying therapy for Alzheimer’s disease. Aducanumab has been studied in amyloid-positive Alzheimer’s patients 50 years or older, who have mild cognitive impairment or dementia.
The FDA granted accelerated approval to aducanumab based on a reduction in amyloid beta plaques, a surrogate endpoint that has not been confirmed to have a clinical benefit in AD patients.
The FDA is requiring Biogen to conduct a new randomized, controlled clinical trial to verify the drug’s clinical benefit. If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug.³
Cost: The average annual wholesale acquisition price (WAC) is $56,000 per patient. This significantly surpasses the $8,300 threshold set by ICER4 where the medication could be considered cost-effective.
Benefit: Medical benefit, intravenous administration
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