US health authorities have just authorized the marketing of a new drug against Alzheimer’s, a first since 2003. But post-authorization clinical trials must be conducted to verify the clinical benefits of the product.
- Called Aduhelm, this treatment is the first to directly address the cause of the disease by aiming to reduce amyloid plaques in the brain.
- It uses a molecule called aducanumab which is a monoclonal antibody that aims to dissolve beta-amyloid aggregates.
- Last November, a committee of experts issued a negative opinion on the authorization of the drug.
This is a first for almost 20 years. A new drug against Alzheimer’s was authorized this Monday, June 7 in the United States by the Medicines Agency – the Food and Drug Administration (FDA). However, this marketing authorization is subject to conditions. The FDA has asked the manufacturer to continue post-approval clinical trials to verify its clinical benefits.
A drug against the cause of the disease
Called Aduhelm, and produced by the pharmaceutical company Biogen, this treatment is the first to directly attack the cause of the disease. The drug aims to reduce “the presence of amyloid plaques in the brain”, clarified the FDA in a statement. For this, it uses a molecule called aducanumab. This monoclonal antibody aims to dissolve aggregates of beta-amyloid, the protein that accumulates and creates plaques in the brain tissue of patients with Alzheimer’s.
Last November, a committee of experts issued an unfavorable opinion on the possible marketing of the drug. The panel judged that the treatment was not sufficiently proven. It was based on two studies with contradictory results. The first concluded on the effectiveness of the drug which would have made it possible, according to Biogen, to reduce amyloid plaques significantly, to trim cognitive decline by 23% compared to a placebo, and to slow down the loss of memory by up to 40%. autonomy. The second study provided negative results. If the conclusions of this committee are only an opinion and do not oblige the FDA, it is rare to see the latter not following them.
A conditional authorization
This time, the United States Medicines Agency decided not to follow the advice of the expert committee and to authorize the sale of the drug. “The FDA has determined that there is substantial evidence that Aduhelm reduces amyloid plaques in the brain and that the reduction of these plaques is reasonably likely to result in important benefits for patients.“, she justified in her press release. Thus, the Agency has “concluded that the benefits (…) outweigh the risks”. Nevertheless, the latter prefers to play it safe by granting only a conditional authorization, a possibility which had not been studied by the committee. “FDA directs Biogen to conduct post-approval clinical trials to verify drug’s clinical benefitssaid the American regulator. If the drug does not work as expected, we may take steps to remove it from the market.”
The arrival of the new drug was received with some reservations. For the American organization Alzheimer Association, this new treatment is very good news. “We welcome this historic decision“, she reacted in a tweet. For the professor of neuroscience at University College London, John Hardy, quoted by AFP, the enthusiasm is more moderate. “While I am happy that aducanumab has received approval, we must be clear that at best this drug will have a profit marginal that will help only carefully selected patients. We will need better drugs in the future.”
On behalf of those impacted by Alzheimer’s and all other dementia, we welcome and celebrate today’s historic FDA approval of aducanumab. This approval is a victory for people living with Alzheimer’s and their families. Read our statement: https://t.co/Neu5MmdDP8 pic.twitter.com/vPbNSdYtDu
— Alzheimer’s Association (@alzassociation) June 7, 2021
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