FDA approval of aducanumab for treatment of Alzheimer’s disease
The Food and Drug Administration approved aducanumab, or Aduhelm, for the treatment of Alzheimer’s disease on Monday.
June 7, 2021
On Monday, the Food and Drug Administration approved the use of the experimental drug Aducanumab for early phases of Alzheimer’s disease. Aducanumab, or Aduhelm, is the first drug that has been approved to treat Alzheimer’s since 2003.
This drug is designed for patients with mild cognitive impairments, not severe dementia, and is also designed to slow the progression of Alzheimer’s disease.
The FDA approved this drug by using their accelerated approval pathway despite public debate on the safeness of this drug. The organization believes that the positive effects of Aduhelm for patients with Alzheimer’s outweigh the risks of the medication. Through the accelerated approval pathway, Aduhelm will be monitored in its effectiveness. If these studies do not prove the benefits of the medication, the FDA is able to remove it from the market.