On June 7, U.S. time, the Food and Drug Administration (FDA) officially approved the use of Aducanumab. This drug will be marketed under the brand Aduhelm. The first new drug for Alzheimer’s disease approved by the FDA in 20 years is also known as the first drug that can prevent or delay the progression of the Alzheimer’s disease and "slow down" the rate of cognitive decline in patients (*Please note that it is not a "cure". The medicine can only be used in the early stages of Alzheimer's disease). This should have been a great thing, because it has brought good news and hope to many Alzheimer's patients, but it has triggered more intense debates in the U.S. medical community about the efficacy and side effects of the drug, and even led to the resignation of two FDA experts! Why did this happen?

This time the FDA specifically stated that the approval of this new drug is under the basis of so-called "accelerated approval pathway" (accelerated approval process - this is an approval process for emergency drugs that can only be used for the treatment of life-threatening high-risk diseases); it put forward strict additional conditions for its manufacturer Biogen, requiring the company to restart a new clinical trial cycle, which is called the fourth clinical trial cycle, or post-approval clinical trial cycle. If the clinical trial fails, then the FDA can withdraw the approval of the drug and take it off the market.

This is because the FDA’s own experts, independent advisory committees, think tanks and American Alzheimer’s experts, even several doctors who participated in the clinical trials of the drug strongly oppose the FDA's approval of the marketing and use of Aducanumab. The opposing party’s reason is that in Biogen’s completed clinical trials, sufficient evidence has not been collected to prove the therapeutic effect of the drug, and in addition, the drug may also cause side effects such as cerebral hemorrhage. If the FDA approves the drug on the market, it will endorse it so that patients who are already suffering from the disease will spend $56,000 a year on the drug (this is the drug price given by the FDA) and fail to get the expected efficacy. This will not only cause direct economic losses to patients, but its side effects may also cause other health damage, which is against medical ethics. Some well-known medical experts directly called it "bad medicine" on TV. We can only wait and see the results of the phase IV clinical trial of Aducanumab!

Which pharmaceutical company doesn't know that Alzheimer's is a market with huge commercial value? The world-famous big pharmaceutical companies have invested in the fierce competition in the research and development of an Alzheimer’s drug, but so far they have invested tens of millions of dollars in research and development, and hundreds of new drugs have failed. Aducanumab was also declared a failure several times. On the day of its approval by the FDA, the stock price of Biogen company soared by 64%, which proved the market's expectation and welcome for the drug: after all, it is the only new drug for Alzheimer's that patients around the world have been waiting for 18 years to see.

The following figure shows the results of the clinical trial of Aducanumab published by Biogen company. Note: in the brain map of group A in this image, the red part is β Amyloid protein, which is considered to cause brain cell lesions, so the lesser the protein, the better. This group of data is the statistics of the clinical trial results of four groups of patients with Alzheimer's disease, which lasted for one year. The data in this figure shows dose-dependent effectiveness: among the dosage of these four groups of patients is 0, 3, 6, and 10mg respectively, the group with the largest dosage reflected the best effect.

The FDA has a precedent for the treatment of Alzheimer’s disease that failed. Tacrine is a precedent that has been approved by the FDA but has been discontinued because of its toxicity. It has been removed from the Alzheimer’s medicine list "Treats cognitive symptoms (memory and thinking)” on FDA’s official website. So we still have to look carefully at the scientific evidence and wait for the results of the fourth phase of the Aducanumab clinical trial.

Why is the FDA so eager to approve this new drug for Alzheimer's Disease Amidst Opposition?

According to statistics released by the US FDA, there are currently about 6.2 million elderly patients with dementia in the United States, of which 5.8 million are Alzheimer’s patients. It is estimated that the number of elderly patients with dementia in the United States will double to 16 million by 2050. Patients with Alzheimer's disease are also doubling at an accelerated rate. The patients are mainly elderly people over 65 years old, of which 80% are elderly people over 75 years old, and 2/3 are female patients. The World Health Organization says that there are about 50 million elderly patients with dementia in the world, and it is increasing at a rate of 10 million new patients every year, of which nearly 70% are patients with Alzheimer's disease. The FDA also admitted that the approval of Aducanumab through the accelerated approval process was due to the pressure of the patient's family members, their support organizations, and some doctors. Patients all over the world are waiting for new drugs!

China is the country with the largest number of patients with Alzheimer's disease in the world, accounting for 1 / 4 of the total number of patients in the world. By 2019, China had more than 10 million patients, and this number is still increasing rapidly with the aging population. It is estimated that the number of patients will exceed 40 million by 2050. According to some data, there are about 201500 elderly patients going missing every year.

Looking at the situation in Japan, Japanese people have the longest average life expectancy and the longest life expectancy for healthy living. However, because the number of elderly people is increasing year by year, the prevalence of dementia in Japan has been pushed to the world's first ranking. According to the OECD, Japan’s Alzheimer’s disease patients accounted for 2.3% of the total population of Japan in 2017. According to Japan’s aging rate, it is predicted that it will account for 3.8% of the total population by 2037. According to the Japan Ministry of Health, Labour and Welfare, in 2020, there will be about 6 million elderly patients with dementia over 65 years old in Japan, and it is expected to reach 7 million by 2025, accounting for 20% of the total elderly population. The beds in Japanese hospitals are mostly occupied by elderly patients who require long-term care. The medical expenses paid to elderly long-term care patients account for 11% of the total hospital expenses, which is much higher than the average 4% of OECD member countries. Japan's annual expenditure on health has already accounted for 10.7% of its national GDP.

Alzheimer's disease was discovered by German psychiatrist and neuropathologist Alois Alzheimer in 1906. However, 115 years later, neither Japan nor the United States, with advanced medical technology, has drugs that can fundamentally cure Alzheimer's disease. Currently, there are five FDA approved drugs in the United States, which can only relieve symptoms or delay the progression of the disease, and are used in the early stage of the disease. Developing drugs that can "cure" Alzheimer's disease is still an unsolved medical problem in the world!