Eisai, Biogen apply for Alzheimer's drug approval in Japan

Eisai Co. and Biogen Inc. hope to gain approval with the Japanese health ministry by the end of the year of an Alzheimer's drug that could both treat the cause and slow symptom progression.

The U.S. Food and Drug Administration granted it fast-track approval earleir in the month.

Eisai, a Japanese firm, had applied with the European Medicines Agency on Jan 9 for approval to sell the medicine in Europe. It 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 US-based Biogen is for early-stage treatment of the fatal, brain-robbing disease.

The drug removes a type of protein called amyloid beta, which 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 its price in the United States at $26,500 per year.

In December 2021, a panel at Japan's health ministry refused to approve another Alzheimer's disease drug jointly developed by Eisai and Biogen.