“Finally, a treatment for dementia has come out”… Alzheimer’s disease first approved

The US Food and Drug Administration (FDA) approved the Alzheimer’s treatment ‘Aduhelm (ingredient name: aducanumab)’ jointly developed by US pharmaceutical company Biogen and Japan’s Eisai on the 7th (local time). AP = Yonhap News

Humanity’s first step towards conquering Alzheimer’s dementia has begun. The US Food and Drug Administration (FDA) approved the Alzheimer’s treatment ‘Aduhelm (ingredient name: aducanumab)’ jointly developed by US pharmaceutical company Biogen and Japan’s Eisai on the 7th (local time). However, some experts in the United States criticize that “the efficacy has not been properly proven,” and the controversy continues. The FDA was aware of this and instructed Biogen to conduct follow-up studies to verify the efficacy of the drug after marketing. This is the so-called ‘Phase 4 clinical trial’. If Biogen fails to demonstrate efficacy in subsequent studies, approval may be withdrawn.

US FDA approval for Alzheimer’s treatment
Expert welcomes “very long-awaited drug”
Some say, “We need to wait for more evidence of drug efficacy”

Dementia experts in Korea greatly welcome it. “This is the first time that a treatment for dementia has been developed,” said Hanna Jo, a professor of neurology at Gangnam Severance. Kim Ki-woong, a professor of psychiatry at Seoul National University Bundang Hospital, said, “We have reached a epochal turning point after 20 years of treatment for Alzheimer’s disease.” Han Seol-hee, a professor of neurology at Konkuk University Hospital, said, “The light of the day has begun to shine on treatment.”

Ad You Helm works by removing amyloid beta protein, a clump of harmful proteins in the brain that causes Alzheimer’s disease. Professor Han Seol-hee said, “The drugs that have been used as a treatment for Alzheimer’s disease are a ‘symptomatic treatment’ that temporarily improves or alleviates the symptoms of the disease, and this new drug is a different kind of drug.” Professor Han said, “This new drug effectively removes amyloid beta protein, an insoluble protein that causes Alzheimer’s disease and is involved in worsening symptoms, from within brain tissue. It has achieved a new era in that it is a ‘causal treatment’,” he added. Reuters reported on the same day that this is the first time that a new drug to fundamentally treat Alzheimer’s has been approved because existing treatments only manage symptoms such as anxiety and insomnia. Patients should receive this drug once every 4 weeks.

According to the Central Dementia Center, the estimated number of dementia patients aged 65 and over in Korea is 750,488 (as of 2018). 10.2% of the elderly population has dementia. It will increase to 1 million in 2024, 2 million in 2039, and 3 million in 2050. 15.3 trillion won (0.8% of gross domestic product) is invested annually, including 2.5 trillion won for treatment costs and 4 trillion won for care costs from long-term care insurance for the elderly. The Central Dementia Center estimates the world’s dementia population to be about 50 million (Alzheimer’s Disease International data).

A researcher at Biogen, an American pharmaceutical company, is working at Biogen's headquarters in Cambridge, Massachusetts.  AP = Yonhap News

A researcher at Biogen, an American pharmaceutical company, is working at Biogen’s headquarters in Cambridge, Massachusetts. AP = Yonhap News

Kim Hee-jin, a professor of neurology at Samsung Seoul Hospital, said, “In Alzheimer’s disease, amyloid builds up and then tau protein builds up, causing nerve cells to change. Amyloid is a protein that acts as a trigger. This new drug eliminates amyloid. It is completely different from previous treatments. It is a drug that dementia patients and their carers have been waiting for.”

It is known that this drug cannot be used in patients with advanced dementia. Professor Han Seol-hee said, “The new drug only applies to Alzheimer’s dementia (meaning it does not apply to alcoholic dementia, etc.). It is also effective only for patients with early dementia or mild cognitive impairment. It is difficult to see the effect in patients who have already progressed significantly.” said. Mild cognitive impairment refers to patients with pre-dementia, and it is possible to prevent them from developing dementia by using new drugs. Kim Ki-woong, a professor at Seoul National University in Bundang, said, “Existing drugs have the function of delaying the worsening of symptoms, and this new drug is meaningful in that they can work complementary to each other.”

There is still a long way to go. Professor Han Seol-hee said, “In addition to amyloid protein, there is a neurotoxic substance called neurofibrillary tangles in the brain of Alzheimer’s patients, and only when a drug that removes them is available, it can be said that Alzheimer’s is completely conquered. Professor Han said, “It is true that this new drug has emerged as a game changer for Alzheimer’s disease treatment, but it is still only half the success.”

The drug was approved after controversy, raising questions about its efficacy. In November of last year, the FDA’s external expert advisory committee did not recommend approval, judging that there was insufficient data to prove the efficacy of the drug. Last year, in a phase 3 clinical trial, the trial was stopped because the results of two studies conflicted with each other. After that, only the high-dose results of the two clinical results were analyzed separately, and it was found that there was a significant effect. The FDA gave the approval conditionally, contrary to the advisory committee’s recommendation. It is also pointed out that Ed You Helm does not restore memory and cognitive abilities, but is effective enough to slow the decline. “Patients and families demand that a new treatment be approved if it is found to be of even small efficacy, while experts have been wary that approving a treatment with questionable efficacy could set a dangerous precedent,” the Associated Press reported.

How much is the loss due to dementia?  Graphic = Reporter Park Kyung-min

How much is the loss due to dementia? Graphic = Reporter Park Kyung-min

There is also a risk of side effects. Professor Han Seol-hee said, “When this drug is administered, amyloid is removed at once, and side effects that damage microscopic cerebral blood vessels may occur in rare cases. If these symptoms appear while taking magnetic resonance imaging (MRI), the drug should be discontinued.” Professor Kim Hee-jin also said, “There is a possibility of side effects such as cerebral edema.”

The high price is also a problem. Biogen announced that it has set the price of Ad You Helm at $56,000 per year (about 62.3 million won). This is more than double the $10,000 to $25,000 per year (about 11.15 million to 27.88 million won) predicted by experts. Professor Kim Hee-jin said, “I’m worried that the drug will be too expensive.”
Biogen conducted a phase 3 clinical trial in 3,285 patients at 348 hospitals in 20 countries, including the United States, Germany, France, Australia, Japan and Taiwan. About 100 Korean patients also participated. It is expected that it will take some time for this drug to enter the country. It must be approved for marketing by the Ministry of Food and Drug Safety, and must go through complicated procedures such as whether to apply for health insurance and how much if it is applied. Negotiating drug prices takes a considerable amount of time. An official from the Ministry of Food and Drug Safety said, “It is too early to judge whether to conduct a clinical trial in Korea.”

Welfare reporter Shin Sung-shik, Esther and Jeong Young-kyo reporters


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