The U.S. Food and Drug Administration has approved the use of Biogen’s Aduhelm drug to fight Alzheimer’s disease.
The FDA has made this decision for the first time in 20 years, despite warnings from independent experts that such treatment does not help to slow the progression of the disease, which destroys the brain.
The agency attributed its approval to a study showing that Aduhelm is “reasonably likely” to benefit patients. According to the researchers, the drug does not reverse the decline in mental development, but only slows the process.
According to FDA consultant Dr. Caleb Alexander, who recommended that Aduhelm not be approved, he was “surprised and disappointed” by the regulator’s decision.
Under the terms of the “expedited approval,” the FDA requires Biogen to conduct a study to confirm the drug’s benefit to patients. If the results don’t show it to be effective, the FDA can remove the drug from the market, although the agency does this extremely rarely.
Biogen said the treatment will cost about $56,000 a year, with no price increase over the next four years. Most patients will not pay because of insurance coverage and other discounts. The company intends to complete a trial of the drug by 2030.
About Aduhelm, it is known to be suitable for patients under the age of 80 and with the initial stages of the disease. Over the past 10 years, more than 100 treatments for Alzheimer’s have been considered, but none have paid off. Many physicians also question the merits of the regulator-approved drug, which destroys a protein that forms clots in the human brain that damage cells and cause problems with memory, thinking and communication.