FDA approves new medicine for Alzheimer

The U.S. Food and Drug Administration (FDA) approved a new medicine for Alzheimer for the first time in 18 years. It is good news to patients with dementia as some 70 percent of senile dementia cases develop from Alzheimer. But whether it can be of help to eradicate Alzheimer is still unknown as there are still controversies among experts on the efficacy of the medicine and it costs tens of millions of won won per year. 　

The FDA gave a conditional approval for Aduhelm co-developed by Biogen, a U.S. pharmaceutical company, and Japan’s Eisai on Monday (local time). Alzheimer patients have to get a shot every four weeks. According to overseas media, previously developed medicines were only able to manage symptoms of dementia, but the new medicine developed for the first time in 18 years carries greater significance as it is used to treat the disease. But the new medicine cannot reverse the disease completely either. Biogen announced on the same day that the cost of the medicine would be around 56,000 dollars per year.

The FDA added a safety feature, which obligates the biopharma companies to have additional clinical trials to check the efficacy of the medicine while approving it. The New York Times reported that some experts are concerned that the approval may lower the standards for new drugs despite this added condition.


Jae-Dong Yu jarrett@donga.com