Lecanemab, an experimental drug for the treatment of Alzheimer’s disease, has received marketing authorization in the United States under the name Leqembi. How effective is it? Its side effects? Will it arrive in France?
On January 6, 2023, the American drug agency FDA (Food and Drug Administration) authorized the US marketing of Lecanemaba new drug whose objective is to slow down the progression of the diseaseAlzheimer. “This is the first time that such clinical effects have been observed. in the case of treatment for Alzheimer’s disease” commented Dr Maï Panchal, General and Scientific Director of the Vaincre Alzheimer Foundation. Lecanemab will be marketed under the name of Leqembi in the United States. It is not not yet authorized in France. Laboratories Japanese Eisai and American Biogen, behind this new drug, wish to file a marketing application in Europe.
Definition: what is Lecanemab?
Lecanemab, also known as BAN2401, is a drug formulated by the Japanese pharmaceutical laboratory Eisai in collaboration with the American laboratory Biogen. It’s a antibody monoclonal which aims to clear the brain of amyloid plaques, ces toxic aggregates that can be observed in the brains of patients with Alzheimer’s disease and which are among the possible causes of the disease. The goal of Lecanemab is to slow down disease progression at an early stage. However, it does not cure Alzheimer’s disease. Lecanemab will be marketed as This group.
Will Lecanemab be available in France?
To date, Lecanemab has received marketing authorization in the United States but is not yet authorized in France. Manufacturers will first have to obtain authorization from the European Medicines Agency (EMA) and then from the National Agency
safety of medicines and French health products (ANSM).
For which Alzheimer’s patients?
This medicine is intended for patients with cognitive disorders mild or with mild-stage Alzheimer’s disease and whose examinations confirmed the presence of cerebral amyloid plaques.
What is the dosage of Lecanemab?
10 mg per kilo of Lecanemab should be administered every 2 weeks by perfusion intravenous. A brain MRI before the start of treatment and periodic monitoring by MRI before the 5th, 7th and 14th infusions are prescribed.
What are the side effects of Lecanemab?
This treatment can induce side effects such as micro-hemorrhages or cerebral edemas. They are, in the majority of cases, controllable and without serious consequences, but they must be monitored with regular MRI sessions” points out Dr. Marion Levy, Head of Studies and Research at the Vaincre Alzheimer Foundation in a communiqué published on January 7, 2023. Migraine, cough and diarrhea are some of the other reported side effects.
What are the contraindications?
“Caution should be exercised when considering the use of this treatment in patients with risk factors forhemorrhage intracerebral” indicates the Biogen laboratory. The use of anticoagulant drugs is contraindicated in case of treatment with Lecanemab.
How effective is Lecanemab on Alzheimer’s disease?
In the Phase 3 clinical trial, “Lecanemab treatment has shown a 27% reduction in cognitive decline in 18 months” reports the Vaincre Alzheimer Foundation. Cognitive and functional performance was assessed in six different areas: memory, l’orientation, judgment and problem solving, social activities, home and leisure, and personal care. “Lecanemab showed a sharp decrease in the accumulation of cerebral amyloid plaques in Alzheimer’s patients and a slowing of cognitive decline“says Dr. Maï Panchal, General and Scientific Director of the Vaincre Alzheimer Foundation. “This pathology is multifactorial, we must not forget that. The accumulation of the tau protein in the brain of patients is also at the origin of the symptoms. Inflammatory, metabolic, vascular and genetic pathways also come into play. To halt cognitive decline, it will then certainly be necessary to set up several treatments targeting different molecular targets“says Dr. Panchal.
What is the price of Lecanemab?
In the United States, it would be marketed between 8,500 dollars and 20,600 dollars per year for patients, which corresponds to a cost including between 7,921 and 19,196 euros per year.
Sources :
– Alzheimer’s treatment: lecanemab soon on sale in the United States, Fondation Vaincre Alzheimer, January 7, 2023
– FDA Approves LEQEMBI™ (lecanemab-irmb) Under Accelerated Approval for Treatment of Alzheimer’s Disease, Biogen, January 6, 2023
– Lecanemab in early-stage Alzheimer’s disease, The New England Journal of Medicine, January 5, 2023
– Lecanemab: confirmation of a treatment that reduces cognitive decline in early-stage Alzheimer’s patients, Fondation Vaincre Alzheimer, September 28, 2022