Has the FDA Alzheimers drug approval been announced too early?
Decades of a one-child policy has built in a demographic challenge for China, with a low birth rate and the world's largest population of elderly to provide for - Copyright AFP WANG ZHAO  The U.S. Food and Drug Administration (FDA) has granted approved for a drug named aducanumab (manufactured by Biogen/Eisai). The drug, according to NPR, is designed to treat Alzheimers disease. It is a human monoclonal antibody. What is important about the announcement is that this is the first drug that is clinically shown to slow the progression of Alzheimers disease. The evidence based approach has laid the foundations for the beginning of a completely generation of Alzheimers treatments. The drug has been assessed across three trials. These studies show that the drug reduces amyloid in brain. The data assessment indicates there is a reasonable likelihood that the level of amyloid reduction will result in clinical benefit. It is important to point out that aducanumab is not a cure. However, it is a very important advance for treatment. Furthermore, the therapy has not yet been tested on people with more advanced cases of dementia. Over the past few decades, many researchers have argued that the accumulation of toxic beta-amyloid in the brain causes Alzheimers disease. Amyloid plaques are aggregates of misfolded proteins. These abnormally configured proteins form in the spaces between nerve cells, first developing in the areas of the brain concerned with memory and other cognitive functions. Amyloid is formed by the breakdown of larger protein molecules. Instead of being cleared (as in a normal brain) the proteins build up to abnormal levels, which causes a toxic effect. As the beta-amyloid proteins find each other, they aggregate or clump, forming plaques. The intention of the medication is to provide people living with Alzheimers more time to live better. Commenting on the announcement, Dr. Joanne Pike, who is the chief strategy officer for the Alzheimers Association, said: This therapy will be of great interest to many, but it is not the only important element of Alzheimers treatment and care.  With the FDA decision, this is a drug ruling known as accelerated approval. This is common with drugs for cancer, but it has not been granted previously for a treatment for Alzheimers disease. It is expected that the announcement will lead to an increase in investments in new treatments, as well as encouraging further innovation. However, not every advocate body is sold. Some organizations, such as The American Geriatrics Society, views the approval as premature given the lack of sufficient evidence to support that aducanumab reduces progression of Alzheimers disease,