Japanese pharmaceutical firm Eisai Co. said Monday it and U.S. firm Biogen Inc. applied with the health ministry for approval of an Alzheimer's drug that could become the first available in Japan that both treats the disease's cause and slows symptom progression.
The two companies hope to gain approval by the end of the year following the U.S. Food and Drug Administration's decision earlier in the month to grant it fast-track approval.
Eisai said it had applied with the European Medicines Agency on Jan. 9 for approval to sell the medicine in Europe. The firm also submitted the drug data to China's National Medical Products Administration in December.
Using an antibody called lecanemab, the new drug co-developed by Eisai and Biogen is for early-stage treatment of the fatal, brain-robbing disease.
The drug removes a type of protein called amyloid beta, which is considered the cause of the disease. The protein accumulates inside the brain and destroys nerve cells, Eisai said.
The firm said clinical trials demonstrated the new drug curbed the progression of symptoms, such as worsening memory and impairment in judgment, by 27 percent compared with a placebo.
According to the clinical trial results, 12 to 17 percent of those who were administered the drug showed side effects, such as brain edema and bleeding, compared with a group who took a placebo, but most of those who had the side effects only suffered mild to moderate symptoms temporarily, Eisai said.
It is expected that the drug will be expensive after Eisai set it's price in the United States at $26,500 per year.
The Alzheimer's Association, a U.S.-based nonprofit organization, said 55 million people in the world are living with Alzheimer's and other forms of dementia.
A research team at Japan's Ministry of Health, Labor and Welfare has estimated 6.75 million people will suffer from dementia in Japan in 2025. In 2014, the total costs for dementia patients in the country, including medical and nursing care, were 14.5 trillion yen ($113 billion).
In December 2021, a panel at Japan's health ministry refused to approve another Alzheimer's disease drug jointly developed by Eisai and Biogen.
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