New Drug for Alzheimer’s Disease Treatment Approved by FDA

In a breakthrough development with regard to Alzheimer’s Disease Treatment, a New Drug [aducanumab] to Cure Alzheimer’s Disease has been Approved by US Food and Drug Administration (FDA).

On Monday the 7th of June 2021, the US Food and Drug Administration (FDA) approved aducanumab for the treatment of Alzheimer’s disease. This is the first time in nearly 20 years a medication has been approved for Alzheimer’s disease.

Although the drug has not been approved in any other country yet, it is expected the public might be interested to know the following about the new medication:

  1. Aducanumab is a monoclonal antibody that works against beta-amyloid, a protein that is deposited in the brain of Alzheimer’s patients. There is evidence to indicate that beta-amyloid protein plays a significant role in the development of Alzheimer’s disease.
  2. Aducanumab approval is based on the results of two randomised clinical trials. Those trials showed that the drug successfully removes amyloid from the brains of Alzheimer’s patients. However, it is not clear whether the drug resulted in significant clinical improvement. One of the studies showed that progression of cognitive decline was  20% slower, which was seen mostly in those who received higher doses.
  3. The effectiveness of the Aducanumab has only been confirmed in patients with early-stage Alzheimer’s disease. There is no evidence that this drug could help with advanced Alzheimer’s disease due to the degree of damaged the brain would have endured at those late stages.
  4. As all medications, Aducanumab has side effects, some of them are serious and potentially dangerous. It is reported that between 3 and 4 in 10 patients who receive aducanumab develop a brain inflammation, which involves brain bleeding, brain swelling, or a combination of the two.
  5. It is expected that for patients to be illegible to receive Aducanumab, they will have to undergo rigorous and advanced investigations to assess their suitability to receive this treatment and to reduce the risk of them having serious side effects.