First drug to treat Alzheimer's disease approved

Eisai and Biogen's Leqembi (lecanemab) was the first drug approved for the treatment Alzheimer's disease in Europe.

Alzheimer's disease is the most common form of dementia, a neurodegenerative disorder first described in 1907 by German psychiatrist Alois Alzheimer (1864–1915). It is usually found in people over 65, but there is also early Alzheimer's disease, a rare form of the disease. By 2050 the number of patients could increase till 100 million people.

Lekambi, developed by American multinational Biogen and Japanese company Eisai, is the brand name for an active substance called lecanemab, which is used to treat adults with mild memory problems and cognitive impairment that occurs in the early stages of a common type of dementia.

The EMA approved the drug only for patients at low risk of potential brain bleeding: those with "only one copy or no copies of ApoE4," a type of gene known to be an important risk factor for Alzheimer's disease.

Alzheimer's disease researchers and charities have high hopes for Lecanemab due to the fact that it affects the causes of the disease rather than the symptoms.

It works by using antibodies that bind to and clear out proteins that typically build up in the brains of people with Alzheimer's disease, the most common type of dementia.

Clinical trials have shown that the drug can slow the progression of the disease by 27% compared to placebo. It has previously received registration in the United States, Japan, China, Great Britain, Mexico and other countries.

The procedure for reviewing the application for drug registration lasted more than two years.

Last month, EMA rejected Eli Lilly's application for Kisunla (donanemab) to treat Alzheimer's disease, saying its benefits did not outweigh the serious safety risks.