In February, the Federal Drug Administration (FDA) requested additional testing and data for aducanumab, a promising new drug for Alzheimer’s disease. The FDA pushed the date to July 7, 2021, before making its decision to approve the new treatment.
“If approved, aducanumab would be the first available treatment to potentially change the progression of Alzheimer’s, not just the symptoms, for millions of people facing the disease today,” said Harry Johns, Alzheimer’s Association CEO in a recent letter.
Aducanumab is an antibody being studied as a potential drug that eases symptoms of Alzheimer’s. Antibodies are made by the immune system to fight viruses and bacteria that make us ill. Aducanumab is cloned from immune cells called “monoclonal antibodies” that may help fight dementia by targeting amyloid beta.
Its phase II and III trials served as a test of the “amyloid hypothesis” that Alzheimer’s is intimately linked to the accumulation of amyloid in the brain. If amyloid accumulation can be prevented or reversed, the disease may be prevented or cured. Studies have suggested that aducanumab binds to amyloid beta tangles and reduces them.
The primary goal of the trials was a measurement that combined performance on mental tests of reasoning and memory with assessments of how well the participants performed in activities of daily living, like dressing themselves and preparing meals.
The drug’s developer, Biogen, specifically claimed that test subjects saw an increased ability to manage finances, do chores around the house, go shopping and leave the home independently. These are instrumental acts of daily living (IADLs) that usually become too difficult for people with dementia somewhere around the middle stages of the disease.
The aducanumab biologic license application is the first filing for FDA approval of a treatment that addresses the clinical decline associated with Alzheimer’s, as well as the pathology of the disease. While it does not reverse or cure the deterioration of the brain, the drug may slow the loss of memory and general cognition that are hallmark symptoms of the disease.
Critics, however, are skeptical. The amyloid hypothesis deduces that reducing the plaques will improve cognition, yet skeptics contend it has not been shown to work in any drugs that previously went for FDA approval. They say a closer look at the trial data shows thinking improvements might be overblown or unrelated to the drug itself. Thus, the debate over whether targeting amyloid beta plaques in the brain improves dementia symptoms.
In addition, aducanumab is expensive, with the annual costs projected to be around $50,000 for the recommended dosage. PET brain scans to detect amyloid beta plaques would probably be necessary to determine the dosage, and those are expensive as well. Centers for Medicaid and Medicare Services will have to determine the extent to which Medicaid and Medicare will cover aducanumab if the cost is high and the drug’s effectiveness remains in doubt.
“Alzheimer’s disease remains one of the greatest public health challenges of our time,” said Michel Vounatsos, CEO at Biogen. “It robs memories, independence and eventually the ability to perform basic tasks from the people we love.”
For more information, contact Alzheimers Coachella Valley at (760) 776.3100 or visit www.cvalzheimers.org.
1) Harry Johns, CEO, Alzheimer’s Association;
3) https://www.nytimes.com/2021/01/11/health/alzheimers-amyloid-lilly.html; 3) https://www.biospace.com/article/-fda-extends-review-period-for-biogen-s-alzheimer-s-drug-by-another-3-months/;