US drug agency approves drug for Alzheimer’s – despite serious side effects, victim Jeremy Renner jokes in intensive care video

The U.S. Food and Drug Administration (FDA) has granted accelerated approval for an antibody drug designed to slow the progression of early-stage Alzheimer’s disease. In the weeks before the decision on Friday, there was criticism of the treatment with the antibody lecanemab, because test series had shown side effects such as brain swelling and bleeding in the brain.

The drug, developed under the name Leqembi by the American company Biogen together with the Japanese pharmaceutical company Eisai, was tested in series of tests with 856 Alzheimer’s patients, the FDA said. Those treated with Leqembi would have achieved significantly better results than a placebo group. The companies emphasize in the description of the drug that it is only suitable for mild and early cases of the disease. An application for market approval is also planned in Japan and Europe by the end of March 2023.

In November, an international study concluded that the drug slows the progression of Alzheimer’s disease. The researchers wrote in the New England Journal of Medicine that the safety of the treatment should be further investigated in longer studies. The “Accelerated Approval” now granted allows for the use of drugs for diseases with an unmet need while conducting more extensive sets of tests.

The researchers had reported the significant side effects. There were no deaths as a result of the treatment. At the end of December, however, an article appeared in the journal “Science”, according to which three deaths may have been related to the therapy.

Alzheimer’s disease is characterized by deposits of proteins in the brain years before the first symptoms appear. The lecanemab antibody captures the protein amyloid-beta (Abeta) in the patient’s brain, where it is deposited in the form of so-called plaques. These plaques are a key feature of Alzheimer’s disease and are considered one of the causes of the disease.

The condition is the most common form of dementia. According to the German Alzheimer’s Association, approximately 1.8 million people in Germany are living with dementia, most of whom have Alzheimer’s. This leads to the death of nerve cells in the brain, leading to forgetfulness, confusion, speech disorders or disorientation. The disease progresses slowly, making it increasingly difficult for those affected to cope with everyday life. (saw/sda/dpa)