On Monday, the Food and Drug Administration approved Biogen’s Alzheimer’s drug “Aducanumab.” However, some experts are a bit skeptical of the new treatment.
What We Know:
- Aducanumab, also known as Aduhelm, is the first drug approved by U.S. regulators targeted at Alzheimer’s in 20 years. Over six million Americans live with Alzheimer’s, which is the most common form of dementia, and it is predicted that the number will be closer to 13 million by 2050.
- Aduhelm focuses on the brain’s deterioration of those with the disease and not just the symptoms that come along with it. It is a “monoclonal antibody administered via a monthly infusion” and targets the amyloid protein that accumulates in patients’ brains and is said to cause progressive dementia.
Harry Johns, CEO of the Alzheimer’s Association, stated, “this approval allows people living with Alzheimer’s more time to live better. For families it means being able to hold on to their loved ones longer. It is about reinvigorating scientists and companies in the fight against this scourge of a disease. It is about hope.”
- Biogen halted production of the drug in May 2019 due to reports of it not being beneficial to those with Alzheimer’s. After months of further research and the backing of the FDA, the company re-started production on the highly anticipated drug. However, a group of experts has stated the FDA refused to endorse the drug due to a lack of “convincing data” and a high price tag.
- The push for Aduhelm came from advocacy groups and those living with the life-threatening disease. Jenny Knap, 69 with mild cognitive impairment, has been receiving the drug for about a year as part of the clinical trial, and stated: “I can’t say if I noticed it on a daily basis, but I do think overall, I’m doing much better in terms of looking for where my glasses are…things like that.”
- According to POLITICO, since the approval went through the FDA’s accelerated approval process, Biogen has to conduct a new clinical trial. If the company doesn’t finish by the given deadline, then the FDA can discontinue the drug. Despite the agency acknowledging that they still have to work to do and that the benefits outweigh the harms, some medical professionals still aren’t convinced.
David Knopman, a clinical neurologist at the Mayo Clinic, stated: “I’m worried about the inconclusiveness of the current data and the possibility that the effect the drug showed in those two trials was no better than no treatment.”
Biogen is said to bring in billions of dollars with the production of Aduhelm. The company promises the drug will be financially accessible to those who need it, despite the wholesale cost being about $4,312 per infusion, making the annual cost around $56,000 for a high dose.
