The US Food and Drug Administration (FDA) today announced the approval by the accelerated procedure of
-aducanumab-, from the North American biotechnology company specializing in neuroscience
, for the treatment of Alzheimer's.
Aducanumab is a monoclonal antibody that binds and
can reduce beta-amyloid plaques present in the brain of
, thus eventually slowing the progression of the disease.
accelerated route used by the regulatory agency
is used for drugs indicated in the treatment of serious diseases or those that compromise survival when they provide a significant therapeutic advance compared to existing alternatives.
, director of the FDA's Center for Drug Evaluation and Research,
has pointed out
, the alternatives currently available for Alzheimer's "only treat the symptoms of the disease," while the treatment approved today
"is the first therapy. which addresses the fundamental pathophysiology of the disease
"As seen in the fight against cancer, accelerated approval can deliver treatments to patients in a more agile way, while continuing to research and innovate."
The first since 2003
Aduhelm is the
first treatment of its kind to receive FDA approval
for this disease, and it is also the first to be licensed by the American Alzheimer's Agency since 2003. For approval, the agency has relied on the efficacy results of Aduhelm in
three different studies among a total of 3,482 patients
, of which those who received the drug experienced a significant reduction in beta-amyloid plaques dose-dependent and associated with the duration of treatment, quantified with PET studies, while those who received placebo had no reduction.
Under the terms of the expedited approval,
the FDA requires Biogen to conduct a new randomized controlled trial
to verify the clinical benefit of the drug, which could be withdrawn from the authorization issued today if it does not achieve this goal.
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