A controversial drug against Alzheimer’s disease, which was presented as the first to treat this neurodegenerative condition, has been withdrawn from the market, its American manufacturer Biogen announced on Wednesday.
The American drug agency, the FDA, gave the green light in June 2021, via an accelerated procedure, to this treatment called Aduhelm.
The decision made waves in the scientific and medical communities because the FDA had gone against the advice of a committee of experts, which had ruled that the treatment had not sufficiently demonstrated its effectiveness during clinical trials.
Several members subsequently resigned from their roles on the committee in protest. A parliamentary report also denounced an authorization process “filled with irregularities”.
Biogen said it was stopping production of Aduhelm to devote more resources to Leqembi, a newer Alzheimer’s drug that was approved last year following a standard procedure.
“In the search for new drugs, a breakthrough can be the foundation that enables the development of future drugs,” said Christopher Viehbacher, CEO of the Massachusetts-based pharmaceutical company.
“Aduhelm was the groundbreaking discovery that paved the way for a new generation of treatments and revitalized investment in the field,” he added.
Aduhelm was the first drug directed against what is believed to be the mechanism of the disease itself, namely the presence of beta-amyloid plaques in the brain, and not just its symptoms.
It was tested in two human trials and showed a reduction in cognitive decline in one study but not the other.
According to a 2022 parliamentary report, the FDA reviewed Aduhelm in the “traditional” manner for nine months, “before abruptly changing course and granting authorization under the accelerated approval process after a period of three-week exam.
“The FDA’s interactions with Biogen were atypical” ahead of the authorization and the agency did not keep track of all interactions between its employees and those of the company, as is normally required, they said. underlined its authors.
The report also blamed Biogen for setting a very high price in an “unjustified” manner ($56,000 per year) in order to “maximize” its profits.
Leqembi, also marketed by Biogen, is now the only treatment authorized in the United States for Alzheimer’s. It also targets beta-amyloid plaques and, according to studies, modestly reduces cognitive decline in patients with an early stage of the disease.
Donanemab, developed by Eli Lilly, could be next to get the green light from authorities after similar performance in clinical trials.
