In the middle of the debate about the Alzheimer’s drug approval, the United States FDA has authorized Aduhelm, the very first Alzheimer’s medication in the last two decades, which is manufactured by Biogen Pharma.
“Aduhelm is an antibody that attacks the amyloid plaque that has been found to accumulate in the brains of people who have Alzheimer’s disease,” said Dr. Jeffrey Singer to The National Desk’s Jan Jeffcoat. “The only problem is that there’s still a lot of controversy among researchers as to whether or not those plaques are responsible for dementia or are a byproduct of some sort of another inflammatory process that’s causing dementia.”
The three executives of the expert committee of FDA have resigned in protest of Aduhelm’s approval. Dr. Singer said that the FDA has an expedited system for approval of drugs which makes these medications easily accessible by patients who may not have any time to wait.
Dr. singer claims that before 1962, FDA was only obliged to verify a drug’s safety and accurate labeling, not its efficacy.