The US Drug Administration approved the first new drug for Alzheimer's disease in recent 20 years.

The new drug, named Aduhelm, was developed by Baijian, an American biotechnology company, and was approved by the US Drug Administration through the "accelerated approval" channel. Accelerated approval allows drugs to be approved before the final clinical results are obtained. However, drugs approved in this way must also pass a post-approval test, and drugs that fail to pass this test to verify their efficacy will be withdrawn from the market according to the relevant procedures of the Drug Administration.

Alzheimer's disease (AD) is a degenerative disease of nervous system, and its clinical manifestations are comprehensive dementia such as memory disorder, aphasia, executive dysfunction and personality and behavior changes. The cause is still unknown. The abnormal accumulation of β -amyloid is one of the early manifestations of Alzheimer's disease, which will eventually form plaques in the brain and destroy the function of synapses.

According to the FDA, the prescription information of the drug shows that the drug will cause abnormal imaging of amyloid, but it will disappear after a period of time; In addition, allergic reactions such as angioedema and urticaria may occur. Other common side effects include headache, falls, diarrhea and confusion.

According to American media reports, some American medical experts believe that the drug is aimed at the underlying pathophysiological mechanism of Alzheimer's disease rather than symptoms, and has not been clinically proved to significantly slow down the progress of this degenerative disease, so whether it should be approved is controversial. Patricia Cavazzoni, director of the Center for Drug Evaluation and Research of the US Drug Administration, said that although the clinical data of this drug is very complicated, the US Drug Administration believes that there is a lot of evidence that it can reduce beta-amyloid plaques in the brain, and the reduction of these plaques is likely to bring important benefits to patients.