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>Officials at Alzheimerҳ organizations praised the approval of the medication lecanemaab. Manu Padilla/Stocksy UnitedA new Alzheimerҳ drug, lecanemab, has received approval from federal regulators.The approval comes after the medicationshowed promise in slowing cognitive decline in a phase 3 clinical trialThere are reports that three people died while taking the drug during the trial.Some experts have said lecanemab may simply reduce symptoms and not improve brain function.A new drug to treat Alzheimerҳ disease received approval today from the federal Food and Drug Administration (FDA).FDA officials said the approval Ӳepresents an important advancement in the ongoing fight to effectively treat Alzheimerҳ disease.ԓAlzheimerҳ disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,Ԡsaid Dr. Billy Dunn, the director of the Office of Neuroscience in the FDAҳ Center for Drug Evaluation and Research, in a press statement. Ӕhis treatment option is the latest therapy to target and affect the underlying disease process of Alzheimerҳ, instead of only treating the symptoms of the disease.Ԕhe drug, lecanemab, will be sold under the brand name Leqembi.Some experts have questioned its effectiveness, but the medication showed promise in a phase 3 clinical trial.Researchers said lecanemab slowed cognitive and functional decline by 27% when given to people with Alzheimerҳ in the clinical trialHowever, the journal Science reported in late December that three people died while taking the drug during the clinical trial. The journal reports that the third death was a 79-year-old Florida woman who died in mid-September after developing brain swelling and bleeding.What is Leqembi? Leqembi is the brand name of lecanemab, which is used to treat early Alzheimerҳ disease. In earlier clinical trials, it was shown to lower levels of beta-amyloid plaque, a biomarker of the disease found in the brain.ӌecanemabŠis a monoclonal antibody infusion therapy that targets components of beta-amyloid, which build upŠas part of the plaques and tangles that are characteristic of Alzheimerҳ disease. And these new therapies effectively clear those amyloid plaques. Itҳ an exciting new chapter in the treatment of Alzheimerҳ disease,Ԡsaid Dr. Scott A. Kaiser, a geriatrician and the director of geriatric cognitive health for the Pacific Neuroscience Institute at Providence Saint Johnҳ Health Center in Santa Monica, California.ӗe know that it clears the beta-amyloid plaque,ԠKaiser told Healthline in September. Ӕhe question is whether or not that actually helps with brain function. But the idea is that these plaques are interfering with the effective communication and overall interaction between brain cells and that clearing them could have positive effects.Ԕhe drug is given via an infusion. Side effects of the drug include headache, infusion related reactions and a condition called amyloid-related imaging abnormalities (ARIA). The drug will carry a boxed warning for patients about the potential of ARIA.ARIA can present as swelling and potential bleeding in the brain, usually the issue resolves over time. However, it can result in brain edema that can lead to seizures and other life threatening complications, according to the FDA. Alzheimerҳ organizations react to lecanemab approvalThe FDAҳ approval of lecanemab was met with praise from officials at several Alzheimerҳ organizations.Ӕhis treatment, while not a cure, gives people in the early stages of Alzheimerҳ disease more time to maintain their independence and do the things they love,ԠJoanne Pike, DrPH, Alzheimerҳ Association president and CEO said in a statement. ӗhile we continue efforts to discover new targets and test new treatments, people living with this fatal disease deserve the opportunity to discuss and make the choice with their doctor if an FDA-approved treatment is right for them.Ԕhe reaction was equally positive from the Alzheimerҳ Drug Discovery Foundation (ADDF).Ӕhis is encouraging news, and more importantly, the approval of Leqembi will serve as a catalyst for driving further developments and investments in the Alzheimerҳ pipeline,ԠHoward Fillit, MD, Co-Founder and Chief Science Officer of ADDF said in a statement. ӗe finally have clarity around amyloidҳ modest effect on cognitive decline. Now, it is more important than ever to double down and widen our focus to developing the next generation of drugs based on the biology of aging that can lead to a combination therapy and precision medicine approach.Ԅrug will be covered by MedicareThe Centers for Medicare and Medicaid Services announced that they will provide significant coverage of the drug. ӃMS today affirms our commitment to help people with Alzheimerҳ disease have timely access to innovative treatments that may lead to improved care and better outcomes,ԠCMS Administrator Chiquita Brooks-LaSure said in a statment. ӗith FDAҳ decision, CMS will cover this medication broadly while continuing to gather data that will help us understand how the drug works.Ԩis is welcome news for the millions of people in this country and their families who are affected by this debilitating disease.Ԕhe CMS said that people with original Medicare plan will pay 20% coinsurance of the Medicare-approved amount after meeting their Part B deductible. Details from the Alzheimerҳ drug clinical trialThe recent clinical trial was conducted at 235 sites in North America, Asia, and Europe between March 2019 and March 2021. The study involved nearly 1,800 adults ages 50 to 90. All the participants had some form of early dementia or Alzheimerҳ disease. Half of the participants were given lecanemab and the other half were given a placebo.Researchers reported there wasnҴ a significant difference between lecanemab and the placebo at 12 months, but at 18 months it appeared the people taking lecanemab had some clearance of amyloid and less cognitive decline.However, researchers said participants taking lecanemab had a higher percentage of adverse events than people taking the placebo at both 12 months and 18 months.The toll from Alzheimerҳ diseaseItҳ estimated that nearly 6 million people in the United States are living with Alzheimerҳ disease.Alzheimerҳ disease is a form of dementia that can progress from mild memory loss in the early stages to the potential for a person with the disease to have difficulty engaging in conversation or responding appropriately to what is around them.There is currently no cure for Alzheimerҳ disease, and treatment options are limited.Ӕhere arenҴ a lot of alternatives, particularly when it comes to drugs. There are drugs that can boost certain levels of neurotransmitters and, otherwise, potentially enhance cognition. But they donҴ modify the actual underlying disease pathology or disease course,ԠKaiser said.Ӕhere are some minor symptomatic treatments. Itҳ akin to cough syrup for somebody who has a cold. It doesnҴ actually cure or treat the underlying cold, it can just provide some symptomatic relief. And in terms of pharmacotherapy for Alzheimerҳ diseaseŠthatҳ all there is. Thatҳ all thatҳ been approved in decades,Ԡhe added.Some hesitation about lecanemabLecanemab was granted breakthrough therapy designation by the FDA in June 2021.This status is designed to speed up the development of new drugs that will address medical needs that are currently unmet for serious or life-threatening conditions.However, some scientists have expressed concern that the earlier phase 2 trials of lecanemab had flaws and that the actual benefit of the drug to people could be limited.Ӕhe phase 2B lecanemab studies were fatally flawed because the high dose versus placebo analysis (that supposedly showed some clinical benefit) was profoundly compromised,ԠDr. Michael Greicius, a professor of neurology and neurological sciences at Stanford University in California, told Healthline in an earlier interview.Greicius argued that in the phase 2B trial, people who were carriers of APOE4, a type of gene associated with an increased risk of Alzheimerҳ disease, were prevented midway through the trial from receiving a high dose of the treatment. Ӕhis means that there were many more APOE4 carriers in the placebo group (71%) than in the high dose group (30%),ԠGreicius explained. Ӕhis difference in percentage of APOE4 carriers is as likely (or in my view more likely) than the drug to account for the difference in clinical outcomes.ԃoncerns with new drugs for Alzheimerҳ diseaseA similar drug, Aduhelm, has been cleared for use.In 2021, Aduhelm received FDA approval as the first new treatment for Alzheimerҳ disease since 2003. It received approval on the basis of the drug being effective at reducing beta-amyloid plaque.Ӕhis approval was met with a great deal of criticism by the scientific community because there are no compelling data to show that reducing amyloid plaque is associated with improved clinical outcomes,ԠGreicius said.ӌecanemab also has a similar profile of dangerous side effects related to brain swelling and brain bleeding that we see with Aduhelm, though lecanemab is probably a bit friendlier than Aduhelm on this front in that ѯnlyҠ10 percent of patients in the high dose groups showed these side effects [in the phase 2 trial],ԠGreicius added.