Alzheimer’s Drug approved by US Food and Drug Administration
Treatment with the antibody lecanemab aims to slow the progression of early-stage Alzheimer’s. However, there were side effects in test series. The US Food and Drug Administration (FDA) has granted fast-track approval to an antibody drug designed to slow the progression of early-stage Alzheimer’s disease. In the weeks leading up to Friday’s decision, the antibody treatment, lekanimab, drew criticism because a series of tests showed side effects such as brain swelling and bleeding in the brain.
The FDA said the drug, which was developed by US company Biogen under the name Leqembi with Japanese drugmaker Eisai, was tested in a series of trials on 856 Alzheimer’s patients. Those who were treated with Leqembi had significantly better results than the placebo group. The companies emphasize when describing the drug that it is only suitable for mild and early cases of the disease. It is also scheduled to apply for market approval in Japan and Europe by the end of March 2023.
Significant Side Effects
In November, an international study came to the conclusion that the drug slows down the progression of Alzheimer’s disease. The safety of the treatment should be examined in longer studies, the researchers wrote in the New England Journal of Medicine. The “accelerated approval” now granted allows the drugs to be used for diseases whose needs have not been met in a more extensive series of trials.
Researchers have reported significant side effects. No deaths occurred as a result of the treatment. But at the end of December, an article appeared in the specialized magazine Science, stating that there may have been three deaths related to the treatment.
Alzheimer’s disease is characterized by the presence of protein deposits in the brain years before the first symptoms appear. The lecanemab antibody captures the beta-amyloid protein (Abeta) in the patient’s brain, where it is deposited in the form of so-called plaques. These plaques are the hallmark of Alzheimer’s disease and are believed to be a contributing cause of the disease.
The condition is the most common form of dementia. According to the German Alzheimer’s Association, around 1.8 million people in Germany suffer from dementia, and most of them have Alzheimer’s disease. This leads to the death of nerve cells in the brain, resulting in forgetfulness, disorientation, speech disturbances or disorientation. The disease progresses slowly, making it increasingly difficult for those affected to cope with daily life.