According to the report of Royesh Biotechnology of the Stem Cell, the US Food and Drug Administration has approved the drug aducanumab for the treatment of Alzheimer’s disease in patients who are in the early stages of the disease. This drug is a monoclonal antibody with the trade name Aduhelm and is manufactured by Biogen. This is the first time in the past 17 years that the FDA has approved a drug for the treatment of neurodegenerative disease. Overall, this is the best news that humanity has heard in the 25 years of clinical research in the field of Alzheimer’s treatment. However, the poor effectiveness of this drug in clinical trials has caused some experts to still not be convinced of its benefits.
Alzheimer’s disease is the most common neurodegenerative disease, affecting about 2 percent of the elderly population. Toxic protein deposits called amyloid plaques are one of the early and main symptoms of Alzheimer’s disease, which are usually associated with amyloid angiopathy in the brain. Early clinical trial data showed that aducanumab effectively cleared amyloid plaques.
But results from two phase 3 studies showed that aducanumab did not improve patients’ cognitive abilities enough. So in 2019, the drug companies halted their trials. Six months later, when they reviewed the results, the companies found that patients who received the highest dose of the drug had lost less cognitive ability and had less amyloid protein build-up in their brains than other patients.
The companies then decided to pursue regulatory approval for the drug, but in November 2020, the FDA’s board of directors voted against it. However, the drug was finally approved by the FDA this week, based on aducanumab’s ability to clear amyloid plaques.
