All articles tagged with #leqembi
Israel is pioneering new Alzheimer's treatments like Leqembi, which can slow disease progression, but access is limited to the wealthy due to high costs not covered by public health, raising concerns about inequality in healthcare.
The European Medicines Agency's human medicines committee has recommended Leqembi (lecanemab) for treating early Alzheimer's disease in patients with one or no copies of the ApoE4 gene, due to a lower risk of amyloid-related imaging abnormalities (ARIA). This decision follows a re-examination of data showing Leqembi's benefits in slowing cognitive decline outweigh its risks in this restricted population. The recommendation includes safety measures like MRI monitoring and a controlled access programme to mitigate ARIA risks. The decision now awaits approval from the European Commission.
The first drug shown to slow Alzheimer’s disease, Leqembi, has had a slow start in the U.S. market, with lagging sales, delayed hospital adoption, and insurance coverage rejections. While offering hope for patients, the drug's limited impact and potential side effects have led to cautious uptake. Challenges include setting up systems for drug delivery, understanding coverage, and identifying eligible patients. Despite these hurdles, the drug's maker, Eisai, remains optimistic about its potential and is working on an injectable version and seeking approval for an easier-to-use form.
The first drug shown to slow Alzheimer’s disease, Leqembi, has faced slow adoption due to limited impact, potential side effects, and challenges in setting up systems for delivering the drug. Major hospital systems have taken months to start using it, some insurers have rejected coverage, and patients may hesitate due to the drug's subtle delay in disease progression and potential side effects. While the drug's maker, Eisai, is working to improve access and coverage, doctors emphasize the need for improved diagnosis and quicker treatment initiation for Alzheimer's patients.
Eisai plans to launch its Alzheimer's drug Leqembi to 1,500 patients in China this year, with expectations of significant growth in 2025 as more convenient blood tests become available. Eli Lilly is also developing a similar treatment and has filed for approval in China. The introduction of blood tests is expected to increase interest in the treatment. However, China's healthcare system is currently ill-prepared to provide timely access to Alzheimer's treatments, with limited diagnosis and treatment rates and a lack of specialty care in rural areas.
Biogen is discontinuing its controversial Alzheimer's drug Aduhelm to focus on other treatments, including its blockbuster drug Leqembi, which was developed with Japan's Eisai and approved in 2023. The decision comes after concerns about the risks of Aduhelm outweighing its benefits, leading Medicare to significantly limit coverage of the drug. Despite discontinuing Aduhelm, Biogen aims to build a leading franchise addressing the multiple pathologies of Alzheimer's disease and patient needs.
Biogen has withdrawn its controversial Alzheimer's drug, Aduhelm, from the market following criticism and irregularities in the approval process by the US FDA. The drug's accelerated approval was highly contentious, and its high price of $56,000 a year for patients was deemed unjustifiably high. Biogen will focus on its newer Alzheimer's medicine, Leqembi, which was fully approved last year. Alzheimer's is the most common form of dementia, affecting more than one in nine people over 65.
Biogen will discontinue the sale of its Alzheimer's drug Aduhelm and halt the study needed for full FDA approval, shifting focus to other treatments. The drug, initially anticipated to be a blockbuster, faced challenges with limited evidence of efficacy and insurance coverage restrictions. Biogen will support the sale of another Alzheimer's treatment, Leqembi, which received full FDA approval. The company will incur a charge of about $60 million for shutting down the Aduhelm program, while patients may soon have another treatment option pending FDA review of a potential drug from Eli Lilly and Co.
Ralph Carmona, a Portland man diagnosed with Alzheimer's, participated in a clinical trial for a new drug called Leqembi, which has been approved by the FDA. The drug showed a 27% average slowing of the disease's progression over 18 months. Carmona's positive response, combined with a healthy lifestyle, has led to a good quality of life. Leqembi is now available to the general population, offering hope for Alzheimer's patients. Other drugs targeting Alzheimer's are also showing promising results, and efforts to accelerate Alzheimer's research are underway.
Arkansas Blue Cross and Blue Shield, the largest health insurance company in Arkansas, has decided not to cover the Alzheimer's drug Leqembi, citing insufficient evidence of its effectiveness and concerns about its risks. The decision also applies to the health plans covering state and public school employees. The drug, which costs $26,500 a year plus additional clinic administration fees, became the first to win full approval from the FDA for slowing the progression of Alzheimer's. Medicare, the U.S. Veterans Health Administration, Arkansas' Medicaid program, and United Healthcare's standard commercial plans have opted to cover the drug. Advocates are urging insurers to reconsider their coverage decisions.
Arkansas Blue Cross and Blue Shield, the largest health insurance company in Arkansas, has decided not to cover the Alzheimer's drug Leqembi, citing insufficient evidence of its effectiveness and concerns about its risks. The health plans covering state and public school employees in Arkansas have also opted not to cover the drug. Leqembi, the first drug approved by the FDA to slow the progression of Alzheimer's, comes with a high price tag of $26,500 per year, plus additional costs for administration. Other insurers, including Medicare, the U.S. Veterans Health Administration, and Arkansas' Medicaid program, will cover the drug.
The U.S. FDA has granted traditional approval for Leqembi (lecanemab), a new drug for the treatment of early Alzheimer's disease. Leqembi is a monoclonal antibody that slows the progression of symptoms by targeting the amyloid protein found in the brains of Alzheimer's patients. However, the drug is only indicated for individuals with proven amyloid protein in the brain and early Alzheimer's or mild cognitive impairment. It has shown some success in reducing amyloid protein deposition but has only modestly slowed the progression of the disease. Screening for Alzheimer's with this drug is not a high priority, and other lifestyle interventions such as diet, exercise, and cognitive training may be more beneficial in reducing dementia risk.
Japan's health ministry has approved the Alzheimer's treatment Leqembi, developed by Eisai and Biogen, making it the second country after the United States to clear its use. Leqembi is an antibody designed to remove sticky deposits of a protein called amyloid beta from the brains of Alzheimer's patients and is the first treatment shown to slow the progression of the disease in the earlier stages. Eisai will conduct a post-marketing special use results survey to collect data on patients administered with Leqembi. The drug will be co-promoted by Eisai and Biogen in Japan.
The FDA has approved Leqembi, the first disease-modifying treatment for early-stage Alzheimer's and mild cognitive impairment, and Medicare has agreed to cover the therapy. Medical centers are working to establish policies and procedures for providing the medication to patients, potentially by the end of summer or early autumn. While there is hope for families and other promising therapies, medical providers remain cautious, recognizing that this is just the first step in developing treatments for complex neurodegenerative diseases.
Some private insurers in states like North Carolina, Pennsylvania, and New York are refusing to cover the newly approved Alzheimer's drug, Leqembi, citing it as experimental and questioning its safety and effectiveness. This decision contrasts with Medicare, which will cover most patients taking the drug. While the majority of patients taking Leqembi will be covered by Medicare, those under 65 with commercial coverage are being denied access to the treatment, leading to concerns of discrimination. The full picture on commercial insurance coverage is still emerging, with some insurers yet to make a decision. The high cost and serious side effects of the drug are factors contributing to the coverage denials.