The hadn’t arrived for eighteen years. A new drug against Alzheimer’s disease has just been approved by the American regulator. “This clearance is significant in many ways,” the US Drug Agency (FDA) said in a statement. Named Aduhelm and produced by the pharmaceutical company Biogen, it is the “first approved treatment for Alzheimer’s disease since 2003,” the FDA said. Above all, it is the first treatment directed against the cause of the disease, “the presence of beta-amyloid plaques in the brain,” she added.
In November, however, a committee of experts ruled against authorization, judging that the treatment had not sufficiently demonstrated its effectiveness. That’s why the FDA said it uses a fast-track procedure that only grants the product conditional clearance – a possibility that had not been explored by the committee. “The FDA asks Biogen to conduct post-authorization clinical trials to verify the clinical benefits of the drug,” said the US regulator. “If the drug does not work as expected, we can take steps to take it off the market. ”
Nearly 6 million Americans live with Alzheimer’s, which is the sixth leading cause of death in the United States but remains a disease against which research has stalled for decades.