Aducanumab receives controversial FDA approval

Biogen’s Aduhelm™ (aducanumab) is approved to treat patients with Alzheimer’s disease

June 13, 2021

Drug name: Aduhelm (aducanumab)
Manufacturer: Biogen
Condition: Alzheimer’s disease

Condition overview

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.

Current treatment

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 overview

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

Prime monitors the drug pipeline

The drug pipeline is full of new, groundbreaking specialty drugs that may help members live better and feel well. Prime focuses on clinical strategies designed to keep clients ahead of drug trends — because it’s easier to manage change when you see it coming.


References

  1. https://www.mayoclinic.org/diseases-conditions/alzheimers-disease/symptoms-causes/syc-20350447
  2. https://www.alz.org/alzheimers-dementia/what-is-alzheimers
  3. https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drug
  4. https://icer.org/news-insights/press-releases/icer-releases-draft-evidence-report-on-aducanumab-for-alzheimers-disease/

Drug names are the property of their respective owners.

Related research

Drug pipeline updates

October 14, 2021

November 2021 decisions expected from the FDA

At Prime Therapeutics (Prime), we’ve positioned ourselves to best prepare our clients to…

Drug pipeline updates

September 30, 2021

Drug Pipeline Quarterly Update: September 2021

These quarterly pipeline wrap-ups include new molecular entity approvals, drugs with approvable status…

Drug pipeline updates

September 12, 2021

October 2021 decisions expected from the FDA

At Prime Therapeutics (Prime), we’ve positioned ourselves to best prepare our clients to…