Alzheimer’s Breakthrough: FDA Grants Full Approval to Revolutionary Anti-Amyloid Drug for Effective Alzheimer’s Treatment!
Alzheimer’s Breakthrough: The FDA recently made a significant decision that could greatly impact Alzheimer’s disease research. They granted full approval to a drug called Leqembi, developed by Eisai and Biogen. This groundbreaking drug, the first of its kind, aims to slow down the progression of neurodegenerative disease.
Leqembi belongs to a group of antibody-based drugs that target a protein called amyloid beta, which plays a crucial role in Alzheimer’s. In individuals with the disease, a misfolded form of amyloid accumulates in the brain over time, leading to the formation of clumps known as plaques. These plaques, along with another misfolded protein called tau, are believed to gradually damage the brain and cause cognitive decline. The goal of drugs like Leqembi is to break down or prevent the formation of plaques, with the hope of stopping or slowing down cognitive decline.
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In January 2023, the FDA gave accelerated approval to a drug called Leqembi. This means that the company was able to provide indirect evidence that the drug would have a positive impact on patients, such as by reducing amyloid plaque. However, they still needed to gather more data and confirm the drug’s benefits in order to obtain regular approval. It seems that Leqembi has now fulfilled that requirement.
Teresa Buracchio, who is currently leading the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, emphasized the importance of this decision. She said, “Today’s decision is the first confirmation that a drug designed to target the main cause of Alzheimer’s disease has shown positive effects in treating this terrible illness.”
During a critical 18-month-long clinical trial that led to Leqembi’s approval, the drug demonstrated a 27% decrease in the progression of cognitive decline compared to a placebo. Patients also performed better on tests that measured their everyday functioning and had lower levels of amyloid in their brains.
However, it’s important to note that anti-amyloid drugs, including Leqembi, have potential side effects. One common complication is known as amyloid-related imaging abnormalities (ARIA), which can be detected through MRI scans. ARIAs are usually caused by temporary brain swelling, but in rare cases, they can indicate life-threatening bleeding. While most ARIAs resolve without issue and many patients experience no symptoms, there have been instances of deaths linked to ARIAs and these types of drugs.
The risk of ARIA, particularly severe cases, appears to be higher in individuals carrying a specific Alzheimer’s-related mutation called ApoE ε4. The use of blood thinners may also increase the risk of severe brain bleeding in these patients. Consequently, the drug’s labeling will recommend doctors to test patients’ ApoE ε4 status before prescribing Leqembi and exercise caution if patients are taking blood thinners.
Leqembi’s traditional approval avoids the controversy surrounding other anti-amyloid drugs. In June 2021, the FDA granted accelerated approval to a drug called Aduhelm, also developed by Biogen and Eisai. The supporting data for Aduhelm’s approval was considered weak, leading to protests from many outside experts and criticism of the FDA’s decision. Medicare subsequently decided not to routinely cover Aduhelm and similar drugs approved through accelerated pathways until clear evidence of their benefits was collected. The FDA faced significant criticism from lawmakers for the irregular approval of Aduhelm, and the drug’s manufacturers have delayed plans to seek approval elsewhere.
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Unlike Aduhelm, Leqembi will not be affected by the new Medicare policy. Additionally, Leqembi’s current list price is half of what Aduhelm initially cost, which contributed to widespread criticism of the latter drug. Nonetheless, some researchers argue that the clinical benefits of Leqembi may be too modest to generate significant excitement among patients and doctors at this time. However, advancements in this drug class are evident. In May, Eli Lilly’s donanemab showed promising results, reducing the rate of cognitive decline by 35% compared to a placebo in a large-scale trial.
FAQs
What is the main cause of Alzheimer’s?
Ans. The main cause of Alzheimer’s disease is still not fully understood. However, it is believed that a buildup of certain proteins, called amyloid plaques and tau tangles, in the brain plays a significant role. These abnormal protein deposits disrupt communication between brain cells and lead to the gradual decline of cognitive functions, such as memory and thinking abilities.
What are the signs of Alzheimer’s?
Ans. Signs of Alzheimer’s disease include memory loss that disrupts daily life, difficulty with problem-solving and planning, challenges with familiar tasks, confusion with time and place, trouble understanding visual images and spatial relationships, new problems with speaking or writing, misplacing items and being unable to retrace steps, decreased or poor judgment, withdrawal from work or social activities, and changes in mood and personality.
How to prevent Alzheimer’s?
Ans. While there is no guaranteed way to prevent Alzheimer’s disease, there are steps you can take to promote brain health. These include engaging in regular physical exercise, adopting a balanced diet rich in fruits, vegetables, and omega-3 fatty acids, staying mentally active through puzzles and learning activities, maintaining social connections, getting enough sleep, managing chronic conditions like diabetes and high blood pressure, and avoiding smoking and excessive alcohol consumption.
