Biogen headquarters in Cambridge, Massachusetts. Steven Senne (AP)
The US pharmaceutical company Biogen and the Japanese company Eisai announced on Tuesday that their drug lecanemab has been shown in clinical trials to slow cognitive decline caused by Alzheimer's, the most widespread disease that causes dementia.
The two companies have indicated in separate statements that they will seek regulatory approval of the compound before the US regulatory agency and authorizations for its marketing in Europe and Japan by the end of the first quarter of 2023. Lecanemab is already being reviewed by the regulatory bodies of the United States under a special accelerated approval pathway.
The companies say that a phase 3 trial of 1,795 early-stage Alzheimer's patients shows that giving lecanemab reduces the rate of cognitive decline by 27% compared to those given a placebo.
The drug is a monoclonal antibody that attacks the amyloid plaques of the neurons of the patients, one of the main hypotheses for the origin of the disease, which has not yet been proven.
In the trial, it was administered twice a week for a period of 18 months.
To measure impairment, trained health professionals assess cognitive and functional performance in six areas: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care.
"The results of the lecanemab study support the amyloid hypothesis," says Haruo Naito, Eisai's CEO.
However, numerous clinical trials have failed in this direction and this trial may not close the debate.
Eli Lilly and Roche are also developing compounds that try to obtain clinical benefits in patients by reducing the load of this protein in the brain: donanemab and gantenerumab, respectively.
Although it is the first time that clinical trials have shown such promising results, previous experiences require extreme caution.
Both companies secured approval in 2021 for another Alzheimer's compound — aducanumab, marketed as Aduhelm — despite inconclusive trial results.
The US Food and Drug Administration (FDA) approved the drug against the advice of its group of experts, some of whom resigned in protest.
The European Medicines Agency rejected the request for authorization.
A year after FDA approval, Aduhelm was a clinical and commercial failure, disappointing hopes of dealing with a disease that affects some 50 million people in the world (some 800,000 in Spain).
Biogen announced that it was abandoning its commercialization in May.
Aduhelm was the first Alzheimer's drug approved in nearly two decades and cost $56,000 per patient per year.
This time, the companies assure that the results of the lecanemab clinical trials are successful.
However, details of the study have not yet been published.
"Eisai will present the results of the Clarity AD study on November 29, 2022 at the Clinical Trials Congress on Alzheimer's (CTAD), and will publish the results in a peer-reviewed medical journal," the companies say in their statement.
Following the failure of Aduhelm, Biogen announced the search for a replacement for its chief executive, Michel Vounatsos, which has yet to occur.
"Today's announcement gives patients and their families hope that lecanemab, if approved, can potentially slow the progression of Alzheimer's disease, and provide an impact clinically significant in cognition.
According to Vounatsos, “it is important to highlight that the study shows that the elimination of amyloid beta aggregates in the brain is associated with a slowing down of the disease in patients in the initial phase of it.
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