Lecanemab, developed by Biogen and Eisai, is a monoclonal antibody designed to target and remove beta-amyloid protein, a hallmark of Alzheimer’s disease. Clinical trials have shown promising results, with Lecanemab significantly reducing the accumulation of beta-amyloid in the brain and slowing the progression of Alzheimer’s disease.
The FDA’s approval of Lecanemab has been met with excitement and hope from patients, their families, and healthcare professionals. This groundbreaking drug offers a new treatment option for Alzheimer’s disease, a condition for which there has been a lack of effective therapies in recent years.
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Lecanemab, which will be sold as Leqembi, is the first Alzheimer’s treatment shown to slow cognitive decline in a clinical trial.
The drug is manufactured by two biopharmaceutical companies: Eisai in Tokyo, Japan and Biogen in Cambridge, Massachusetts, USA. The drug is a monoclonal antibody, administered intravenously. Once in the brain, the drug removes the amyloid plaques thought to be responsible for the cognitive decline and dementia in Alzheimer’s disease.
The drug has been approved under the FDA’s “accelerated” process, for drugs for conditions with few currently available treatments, and does not require Phase III clinical trial data.
The FDA made its decision on the basis of phase II data, which showed that lecanemab reduced amyloid plaques in the brains of 856 patients, but did not evaluate whether this effect would affect cognitive ability. This is the same mechanism as aducanumab, an antibody also developed by Biogen and Eisai, which was approved by the FDA in 2021.
Despite this, Biogen and Eisai still conducted a phase III trial with lecanemab. The trial, conducted on about 1,800 people with early-stage Alzheimer’s, showed that the drug slowed cognitive decline by 27% after 18 months of treatment. The FDA’s recent approval decision does not take this test into account.
Controversial about efficacy is that it’s unclear whether lecanemab’s 27% effect has any impact on the lives of people with Alzheimer’s disease, or whether it persists beyond 18 months.
According to Eric Reiman, executive director of the Banner Alzheimer’s Institute in Arizona, USA, the real impact could be “an additional six months of recognizing a loved one’s face or performing a favorite activity”. But that’s just a guess, and accurate conclusions will require more research into the drug’s effects in the future, Reiman said.
While these results are not yet available, the FDA said that lecanemab is only used in people with mild cognitive impairment, similar to the group of patients enrolled in clinical trials.
Meanwhile, experts are not sure that the benefits of the drug are worth the risks. According to them, the patients are people with mild cognitive impairment who are still leading normal lives and are put at both health and financial risks – in the US, a year of lecanemab will cost $ 26,500.
In recent months, Science and STAT News reported that 3 participants in a phase III lecanemab trial had died during the trial’s extended phase. (During the extended period, patients on placebo could be given the drug.) These three died from complications related to brain bleeding and seizures.
The researchers suggest that the patient may have died from a range of conditions collectively known as amyloid-associated abnormalities (ARIA). They suspect the antibody weakens brain blood vessels in the process of attacking amyloid plaques. All patients were on anticoagulants at the time of death, which could have made bleeding worse.
Eisai stated that it was not objective to draw conclusions based on individual cases, and that they reported the deaths to the FDA. The FDA approves lecanemab but requires companies to issue warnings with the drug about ARIA.
Controversy surrounding aducanumab, approved by the FDA under an “accelerated” process on June 7, 2021, also raises concerns about lecanemab. Many researchers believe that aducanumab, also commercially known as Aduhelm, has not shown any obvious effects. Even the FDA’s scientific advisory panel recommended disapproval of aducanumab, with an 8-1 vote in favor of disapproval. Three board members resigned immediately after the FDA decided to approve aducanumab. The agency did not hold a public consultation meeting for lecanemab prior to approving the drug.
Since aducanumab was approved, Biogen and the FDA have both been more closely watched by regulatory agencies. A US congressional investigation published in December 2022 found the FDA violated its own rules by guiding Biogen in the aducanumab licensing process. The report says that the drug approval process is “fraught with irregularities” and “raises serious concerns about the FDA’s lax process and about Biogen’s disregard for drug efficacy,” but Congress did not. raise any penalties against the FDA or the companies.
The Centers for Disease Control and Prevention (CMS) refused to cover aducanumab in federal insurance programs, unless patients enrolled in clinical trials, costing most patients more than $28,000. for one year of treatment if the need arises. CMS and some Alzheimer’s clinics have refused to prescribe aducanumab, because of questionable effectiveness.
Despite the controversy, Reiman hopes that the success of lecanemab will open the door for faster Alzheimer’s drug approval in the future. Reiman is currently working with the pharmaceutical company Eli Lilly to test the monoclonal antibody donanemab. The FDA is expected to decide whether to approve donanemab in the next few weeks.