The U.S. Food and Drug Administration (FDA) has approved the drug aducanumab for the treatment of Alzheimer’s disease. This is the first such approval in 20 years. The drug, developed by Biogen, will be available under the trade name Aduhelm.
The drug targets the underlying causes, not the symptoms, of Alzheimer’s disease, the most common form of senile dementia. Aducanumab destroys amyloid, a protein that builds up in the human brain, damaging cells and causing problems with memory, thinking, and communication.
It is estimated that more than 30 million people worldwide, the vast majority over the age of 65, suffer from Alzheimer’s disease. Aducanumab is suitable for patients under 80 years of age and in the early stages of the disease. It will also be necessary to make an accurate diagnosis with the help of a detailed MRI scan.
Over the past 10 years, more than a hundred treatments for Alzheimer’s disease have been considered, but none have proven effective. Aducanumab is not a cure-all, and many doctors have expressed doubts about its benefits. But its approval in the U.S. will provide a major boost to dementia research, which has traditionally been underfunded compared with oncology or cardiology.
In March 2019, an international trial of aducanumab involving 3,000 people was halted at the final stage when it was revealed that the drug, administered as a monthly injection, did not produce positive results compared to placebo.
Scientists have found that patients’ brains function better after taking the medication. Later that year, however, the American manufacturer Biogen analyzed a larger set of data and found that aducanumab significantly slowed the decline in cognitive function at higher doses.