July 7, 2023 – Experts in the Alzheimer’s disease field are using words like “breakthrough,” “celebrate,” and “thrilled” after the FDA gave full approval to a new drug for treating early stages of the disease. Despite the absence of a cure, any new approval brings hope, especially with a drug like Leqembi, which slowed disease progression by an average of 27% in studies. However, there are concerns about rare but potentially serious side effects, such as brain swelling or bleeding, which led the FDA to require a boxed warning on the drug’s label. The cost of the drug, estimated at $26,500 per year, is also a consideration. The drug, Lecanemab, aims to slow progression in individuals with mild thinking and memory issues in early-stage Alzheimer’s, but it does not reverse progress in those already living with more advanced disease. This marks the first-ever traditional approval for a disease-modifying therapy for Alzheimer’s, which is a significant win for patients and families, according to Susan Peschin, president and CEO of the non-profit Alliance for Aging Research. Peschin emphasized that while the drug is not a cure, it can provide substantial benefits to individuals with mild cognitive impairment by delaying disease progression. The drug delayed symptoms of Alzheimer’s disease by more than 5 months compared to a placebo after 18 months of treatment. This additional time can have a meaningful impact on individuals’ daily lives, allowing them more time with their families, independence, and the ability to continue leading meaningful lives. This approval brings hope for those in the early stages of Alzheimer’s disease, and individuals are encouraged to seek assessment from a doctor as soon as possible to take advantage of potential treatment options. However, it is essential to consider the safety of treatment. The drug carries a black box warning, the highest safety-related warning, due to potential risks of serious and life-threatening events. The main concern with Leqembi and other drugs used to treat Alzheimer’s is the occurrence of amyloid-related imaging abnormalities (ARIA) in the brain, which include brain swelling and microbleeds. These risks are generally minimal for many people, but individuals with a genetic mutation called APOE4 are at higher risk. It is crucial to have discussions about these risks with healthcare professionals to make informed treatment decisions. Despite the safety concerns, the full approval of Leqembi was highly anticipated, as the FDA granted accelerated approval in January based on promising initial study results. A second study confirmed the drug’s clinical benefit, leading to full approval. Leqembi addresses the underlying cause of Alzheimer’s disease by reducing the levels of amyloid plaques in the brain. The treatment is administered through intravenous infusions twice a month, but there is hope for a more convenient pill form in the future. Medicare patients may receive coverage for 80% of the drug costs, but certain requirements must be met, including enrollment in Medicare, a diagnosis of mild cognitive impairment or mild Alzheimer’s disease dementia with evidence of beta-amyloid plaques in the brain, and participation in a CMS approved registry for data entry and reimbursement. Looking ahead, drug maker Lilly has completed a Phase III study of another monoclonal antibody called donanemab for Alzheimer’s disease, which is expected to undergo FDA review soon. Despite controversies surrounding the FDA’s approval of Aduhelm, an already approved monoclonal antibody, experts like Michael Weiner remain optimistic about the future of Alzheimer’s treatment. They believe that with advancements in identifying individuals at risk for Alzheimer’s and treating them before symptoms appear, it may be possible to prevent cognitive decline and dementia in the future. As research continues, the Alzheimer’s Association encourages individuals with Alzheimer’s disease and their providers to participate in the ALZ-NET registry, which aims to collect comprehensive information on treatment safety and efficacy for Alzheimer’s disease.
Approval of Alzheimer’s Drug by FDA Raises Hope, Raises Some Safety Concerns
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