The essentials The American Food and Drug Administration (FDA) has just given the go-ahead for aducanumab, a drug developed by Biogen to fight the progression of Alzheimer’s disease. In Toulouse, where the Gerontopole coordinated clinical studies at French and European level, the news was received with enthusiasm.
The news is very important in the fight against Alzheimer’s disease. The FDA has just approved a treatment that brings hope to millions of patients. Aducanumab, a monoclonal antibody made by the Biogen laboratory, would be the first in twenty years of research that could slow the progression of Alzheimer’s disease by acting on senile plaques (amyloid plaques) that gradually destroy the brain.
This approval, eagerly awaited by patient associations and many doctors, will not fail to generate comments. Because the story of aducanumab is not trivial. In the absence of relevant conclusions, the clinical studies were discontinued by Biogen in the medium term. However, upon closer analysis of the final phase of the study, where the doses given to the patients were higher, Biogen found surprising results that led to a marketing authorization application. The FDA has used an expedited process for this approval, but on condition that clinical studies continue to evaluate the drug’s benefits.
According to the pharmaceutical company Biogen, analysis of the first data had shown that aducanumab would reduce amyloid plaques, reduce cognitive decline by 23% compared to a placebo (measured by memory tests) and slow the loss of autonomy by “ 40%. Results that have so far never been achieved by numerous researches.
Not in Europe yet
The news was received with enthusiasm in Toulouse. Professor Bruno Vellas, geriatrician, member of the National Academy of Medicine and coordinator of the Gérontopole at Toulouse University Hospital, is not satisfied with the word “hope”. Toulouse teams coordinated the French and European parts of the clinical trials with thousands of patients around the world. Although it should take at least two years for aducanumab to be approved in Europe, treatment means the end of the long wait.
“This is the first drug aimed at slowing the progression of Alzheimer’s disease. So far we have only had treatments that improve symptoms and are no longer reimbursed in France. Aducanumab is effective in the mild stage of the disease, which means that we can finally offer something for young patients with early detection of Alzheimer’s disease. This development goes hand in hand with the imminent arrival of blood biomarkers for diagnosis. Research stalled for ten years, either we didn’t have the biomarkers, or the treated patients didn’t have amyloid plaques, or the dose wasn’t strong enough … Knowledge is advancing, other molecules are coming.
In the coming years we will have a cascade of positive studies to fight Alzheimer’s disease, ”said Professor Bruno Vellas.