A new Alzheimer's drug slows the progression of the disease in the early stages, according to a study by the manufacturer Eli Lilly. The US pharmaceutical company Eli Lilly announced that an application for approval for donanemab should be submitted to the US Food and Drug Administration (FDA) before the end of this quarter. Experts spoke of "real progress", but also warned of side effects.
The antibody donanemab targets amyloid plaques in the patient's brain. Such deposits of proteins in the brain, years before the first symptoms appear, are characteristic of Alzheimer's, the most common form of dementia.
In an 18-month so-called phase III study with more than 1700 participants, the people who had received donanemab showed around 35 percent less cognitive impairment than those who had received a dummy drug, according to the company.
"Real progress for patients"
The drug Leqembi, which follows a similar approach, was approved in the USA in January. It was developed by the US company Biogen together with the Japanese pharmaceutical company Eisai and contains the antibody lecanemab. However, both drugs have received a lot of criticism due to side effects such as brain swelling and bleeding.
The study results on donanemab are "real progress for the patients," said Frank Jessen, director of the Department of Psychiatry and Psychotherapy at the University Hospital in Cologne, the German Press Agency. In principle, the effect of donanemab and lecanemab is comparable. "For a precise comparison, you have to see the study data and hopefully also gain comparative experience with these substances in the future in Germany."
Donanemab is "unfortunately not a game changer, but it may be a next step in the right direction," said Linda Thienpont, Head of Science at the Alzheimer's Research Initiative. "It can neither cure nor stop Alzheimer's disease, but also, like lecanemab, at least slow down cognitive decline." However, Thienpont once again underlined the sometimes severe side effects - the effect was "bought at a high price".