By Berkeley Lovelace Jr. -
NBC News
The Food and Drug Administration (FDA) on Friday approved an Alzheimer's drug that clinical trials show slows cognitive decline in patients in the early stages of the disease.
The authorization offers hope after repeated failures in the search for effective treatments, despite the fact that the new drug produces side effects, according to experts.
The treatment, called lecanemab, and which will be sold under the brand name Leqembi, is an infusion of monoclonal antibodies that is administered intravenously every two weeks.
A vial of the drug Leqembi.Eisai Co.
The drug was approved on an expedited basis, allowing for early authorization of promising new treatments that "fill an unmet medical need."
At the same time, pharmaceutical companies are forced to carry out additional clinical trials to confirm the benefits of their drugs, otherwise they risk being withdrawn from the market.
According to the agency, its decision was based on a mid-phase trial involving 856 patients with the disease.
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At the end of September, the Japanese pharmaceutical Eisai and the biotech company Biogen, which develop the drug, announced that a phase 3 clinical study with 1,795 patients found that, after 18 months, Leqembi delayed cognitive decline in people by 27%. that they received it.
The FDA said Friday that it expects to review the Phase 3 data "soon."
The regulatory agency did not seek the advice of its advisory committee, as it did before controversially approving Aduhelm, an Alzheimer's treatment developed by Biogen in 2021.
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Leqembi is not a cure, its objective is to stop the progression of the disease
by eliminating the accumulations of beta-amyloid from the brain, a type of molecule that scientists have long considered one of the main causes of the pathology.
Experts say the benefit is small, but anything that allows patients to spend more quality time with family and loved ones is valuable.
The medication
will cost about $25,000 a year for a single patient
, Ivan Cheung, president and CEO of Eisai in the United States, explained to NBC News, sister network of Noticias Telemundo.
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Currently, the Centers for Medicare & Medicaid Services (CMS) limits coverage for targeted treatments for cerebral amyloid angiopathy, a buildup of proteins in the walls of brain arteries, so acceptance of the new drug may be limited at first, Cheung noted.
Three drug-related deaths
Leqembi has raised concerns for his safety.
The deaths of at least three people could be related to the treatment, after the patients suffered inflammation or a brain hemorrhage.
According to company data from the phase 3 trial, about 12.6% of patients who received the drug suffered brain inflammation, compared to only 1.7% of those in the placebo group.
About 17% of those taking the treatment suffered brain bleeds, compared with 9% in the placebo group.
A doctor examines CT scans in a 2018 file photo. Matt York / AP file
Cheung said the company remains "confident" that the benefits of the drug outweigh its risks.
"The disease is devastating," he said, "and brings great emotional turmoil for all the families involved."
Alzheimer's is the seventh leading cause of death in the United States, according to the Centers for Disease Control and Prevention (CDC).
Most FDA-approved drugs are intended to relieve symptoms, not slow the progression of the disease.
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Friday's announcement follows a harsh congressional report released last week, which scrutinized the approval of Aduhelm, the other Alzheimer's drug developed by Biogen, despite an FDA advisory committee concluding it was unlikely to it will work.
The report notes that the regulatory agency failed to meet its own standards and that its approval was "riddled with irregularities."
In response, the activist group Public Citizen sent a letter on Wednesday urging the FDA to postpone its decision on the approval of Leqembi, while additional clinical trials required for full approval are completed.
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Leqembi, however, has defenders.
Donna Wilcock, Associate Dean of Biomedicine at the University of Kentucky, supports their authorization.
The data supporting the drug application is “strong” and the trial results are the best she has “seen for an Alzheimer's drug in 25 years,” she noted.
The Alzheimer's Association has stated that, based on the results of the Phase 3 clinical trials of Eisai and Biogen, the FDA should approve Leqembi for early-stage disease.
The organization urges CMS to reconsider its decision on new treatments for this pathology.
Last year, in response to scant data supporting Aduhelm's approval, they said they would not cover amyloid-targeted treatments unless the patients participated in a clinical trial.
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Expanding the availability of the drug could mean that people would have "many more months to recognize their partners, children and grandchildren," defended María Carrillo, scientific director of the Alzheimer's Association.
In a statement released Friday after the FDA approval, CMS suggested that it might review its stance on coverage of certain anti-disease treatments.
“CMS is reviewing the available information and may reconsider your current coverage based on this review,” the agency said.
