Tampa, Florida 2021-06-07 11:41:15 –
The FDA approved a study drug on Monday aimed at slowing the progression of Alzheimer’s disease.
The FDA approved the use of aducanumab in patients in the early stages of Alzheimer’s disease on Monday. Pharmaceutical companies Biogen and Eisai say the drug not only addresses the symptoms, but actually slows the progression of the disease.
On Monday, the FDA approved a new treatment for Alzheimer’s disease for the first time in almost 20 years.
Aducanumab’s approval faced some hurdles along the way.
NPR The drug reports that it is designed to reduce the accumulation of growing amyloid plaques in the brains of patients with Alzheimer’s disease. Studies have shown that the drug is effective in reducing plaque buildup, but it is not clear whether reducing plaque can improve a person’s cognitive function.
According to NPR, the drug company has completed two major studies of aducanumab, and preliminary data indicate that the drug did not work. However, if the data was reanalyzed and the results were more favorable, the two companies decided to seek approval.
Finally, the FDA presented the results of two major studies. One shows the effect of the drug and the other shows that the drug did not work.
When the FDA’s approval was given in November, Aducanumab’s approval suffered another obstacle. Peripheral and Central Nervous System Drug Advisory Board Asked if it makes sense to consider data from one positive study of drug efficacy. Ten of the panel members voted “no” and one voted “uncertain”.
Questions remain about the efficacy of the drug, but the Alzheimer’s disease group will see approval as a victory.
“We strongly believe that if the FDA approves this treatment, it will be a new day for Alzheimer’s disease.” Harry Johns, The President and CEO of the Alzheimer’s Association told NPR. “This is not a cure. It is a gradual benefit, and potentially that benefit can be very realistic to change the lives of so many people.”
FDA approves drug for use in fighting Alzheimer’s despite lingering questions from key panel Source link FDA approves drug for use in fighting Alzheimer’s despite lingering questions from key panel