The FDA has approved the first Alzheimer’s treatment to slow down cognitive decline. Critics are concerned the new drug doesn’t have enough evidence to guarantee it actually works.
Aducanumab is now the first Alzheimer’s drug to be cleared and approved by the United States Food and Drug Administration (FDA). The Washington Post reports the drug will change the course of the disease by slowing down the deterioration of brain function. The last time an Alzheimer’s drug was approved was in 2003.
The drug was manufactured by the biotech company Biogen; the FDA directs the company to test the drug. Biogen will put together a post-approval study to confirm the drug actually works.
The Washington Post reports the required portion of the program is called accelerated approval, and it “is designed to allow for earlier approval of drugs that treat serious or life-threatening conditions” so that the U.S. health industry can fix urgent or growing medical issues. Laurie McGinley of the newspaper writes.
Scientists, physicians, and health experts will track how well the medication reduces the amount of amyloid plaque found in the brain. In a statement, Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said clinical trials showed the decline in plaque “is expected to lead to a reduction in the clinical decline of this devastating form of dementia.”
However, critics say the way the drug has been handled between the FDA and Biogen is inappropriate. On Monday, Public Citizen said, “the close collaboration between the FDA and Biogen before and after the submission of the company’s marketing application for aducanumab dangerously compromised the integrity of the agency’s review.”