The United States approves the use of Aducanumab: a treatment for Alzheimer's disease
On Monday, June 7, officials from the FDA, the American drug agency, concluded the usefulness of the treatment Aducanumab (Aduhelm®), developed by the pharmaceutical company Biogen, in people with mild cognitive impairment and Alzheimer's in the initial phase and, therefore, this treatment has been approved for its use in the United States.
However, in this resolution, the American health authorities have also requested an additional post-approval clinical trial to verify the benefits of the treatment. If this new trial fails to demonstrate that such benefits exist, the FDA could reverse this decision and withdraw Aducanumab from the American market.
It is the first drug approved since 2003 for the treatment of an increasingly prevalent disease that, according to data from the Alzheimer's Association, already affects more than six million Americans, representing about 12% of its population older than 65 years.
What is Aducanumab?
Aducanumab, marketed under the name Aduhelm®, is a drug from the group of monoclonal antibodies that targets beta 42 protein. This drug is administered intravenously once a month, in an infusion of approximately one hour.
What are the benefits?
Aduhelm reduces the deposition of beta amyloid in the brain, one of the main biological targets in the search for an effective treatment in Alzheimer's disease. This means that it is a drug that can slow down the course of the disease, although, as the FDA pointed out, it does not present sufficiently satisfactory results in the clinical aspect. That is why a new clinical trial has been requested to the responsible laboratory, Biogen.
What type of patient is Aduhelm addressed to?
This treatment is intended for people with a diagnosis of mild cognitive impairment (MCI) or with a diagnosis of dementia type Alzheimer's in the mild phase.
When will it be available in Europe?
Despite the great importance of the news, at the moment Aducanumab is not available in Europe, since to access its treatment you must wait for the approval of the EMA (European Medicines Agency) and the state agencies, in the Spanish case, of the AEMPS (Spanish Agency for Medicines and Health Products).
Ace Alzheimer Center Barcelona, leaders in dementia research and treatment
As an international benchmark in the research of new treatments, Ace Alzheimer Center Barcelona participated in Biogen's clinical trial for the drug Aducanumab. During the clinical trial, we were the sixth center that was able to include the most people in the study worldwide and the first in Europe. Furthermore, with only 15% inclusion failures, we were the most efficient center in the trial.
From Ace Alzheimer Center Barcelona we value very positively the approval of the drug Aducanumab by the FDA. Dr. Boada, who was the principal investigator of the clinical trial at Ace, calls it “much-anticipated and desired news within the Alzheimer's world. From this moment there will be a before and after in the research and treatment of people in mild and moderate stages". In addition, the doctor adds that "it is a breath of hope for families living with Alzheimer's now and in the years to come."
Ace's medical director wanted to point out that it is vital "to make a careful, accurate and timely diagnosis to find the appropriate drug for the appropriate patients. We know that the disease begins before any symptoms, and this should prompt us to make an early detection."
Since 2008, Ace's medical team has performed free memory screenings for people over 50 years of age in order to achieve this goal: to get closer to an early detection, which allows us to predict Alzheimer's before the first symptoms appear.
We appreciate the generosity of the patients and families around the world who participated in the study and, especially, those who agreed to participate in it through Ace Alzheimer Center Barcelona. The collaboration of all brings us closer to achieving our challenge; make Alzheimer's history.