A Japanese health ministry panel gave the green light Thursday for the manufacture and sale of the Alzheimer's drug donanemab-azbt, developed by U.S. pharmaceutical giant Eli Lilly and Co.
After the soon-to-come formal approval by the Ministry of Health, Labor and Welfare, the drug, under the brand name Kisunla, will become the second medicine available in Japan for treating early symptomatic Alzheimer's disease. The drug works by removing accumulated amyloid beta proteins in the brain, slowing the progress of the disease.
Lecanemab, another immunotherapy drug developed by Japan's Eisai Co and Biogen Inc of the United States, was approved for manufacture and sale in Japan last year.
People with Alzheimer's disease suffer from memory loss and cognitive impairment due to a toxic buildup of amyloid and tau proteins, which likely damage the brain cells and lead to a loss of the ability to carry out even simple tasks in their daily lives.
Donanemab proved successful in slowing cognitive and functional decline by up to 35 percent compared to a placebo in a phase three clinical trial after 18 months, the U.S. drug maker headquartered in Indianapolis said last month.
At the same time, some patients given the drug experienced side effects such as cerebral edema and microbleeding. Three deaths are suspected to have been related to the treatment.
The U.S. Food and Drug Administration approved the new drug last month. The price of Kisunla in the United States is set at $32,000 for a course of therapy lasting a year.
There has been a rise in elderly people suffering from cognitive impairment in Japan, with the number of seniors with dementia and mild cognitive impairment estimated to reach 12.77 million in 2060.
