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The MHRA on Wednesday granted a license for Eli Lilly's new Alzheimer's treatment, donanemab, for use in adults with mild cognitive impairment or mild dementia due to Alzheimer's disease. However, the drug will not be available on the NHS, as the National Institute for Health and Care Excellence (NICE) concluded that it "does not currently demonstrate value for the NHS." The health spending watchdog explained that the costs of providing donanemab, including regular infusions and intensive monitoring for serious side effects, outweigh the relatively small benefits it offers to patients, and so it "cannot currently be considered good value for the taxpayer." Helen Knight, director of medicines evaluation at NICE, said: "For NICE to be able to approve a medicine for use in the NHS it must provide additional benefits to patients, and it must also represent a good use of NHS resources and taxpayers' money. Donanemab (also called Kisunla) is a monoclonal antibody drug given by infusion (through a drip in the arm). It targets and reduces beta-amyloid proteins, whose abnormal buildup is associated with Alzheimer's disease. Clinical trial evidence suggests that the monthly injection can slow Alzheimer's disease progression by 4 to 7 months.

According to Alzheimer's Disease International, more than 55 million people worldwide will have Alzheimer's disease by 2020. This figure will nearly double every 20 years, reaching 78 million in 2030 and 139 million in 2050. The WHO Global Status Report for 2021 estimated the yearly global cost of dementia to be more than USD 1.3 trillion, with a projected increase to USD 2.8 trillion by 2030. To date most drugs developed to treat Alzheimer's disease have failed, largely because they target wrong biomarkers and individuals already exhibiting signs of the disease. Once symptoms appear, however, many brain cells responsible for memory and cognition are likely already damaged and beyond repair. Professor Shai Rahimipour in the Chemistry Department at Bar-Ilan University in Israel has pioneered a different approach utilizing theranostics to pinpoint and treat the earliest, pre-symptomatic signs of Alzheimer's disease. Showing promise in stopping progression of the disease before onset of irreversible brain cell damage, Rahimipour's groundbreaking approach has garnered significant attention in the scientific world.

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved lecanemab (Leqembi) for use in the early stages of Alzheimer's disease, following a thorough review of the drug's benefits and risks. Developed by Japanese pharmaceutical company Eisai, lecanemab is the first treatment for Alzheimer's disease licensed for use in Great Britain, with evidence indicating its potential to slow the disease's progression. Although the MHRA has granted a product license for the medicine, there are concerns about its cost and the potential delay before it becomes accessible to NHS patients. Pharmacist Thorrun Govind told Talk TV that the National Institute for Health and Care Excellence (NICE) is expected to make a final decision on its cost and availability by the end of the year. She highlighted that the drug is currently approved for private use, and that NICE will next evaluate it, weighing patient care against the value for taxpayers, with a final decision expected later this year.

Diabetes drugs that also promote weight loss such as Novo Nordisk's Ozempic, becoming a darling of celebrities and investors, are being studied to tackle some of the most difficult-to-treat brain disorders, including Alzheimer's disease. Diabetes regimens, from Ozempic to old mainstays like insulin and metformin, appear to address several different aspects of the metabolic system implicated in Alzheimer's disease, including a protein called amyloid and inflammation, researchers say. The hope is that improving glucose utilisation and tamping down inflammation in the entire body - including the brain - could slow progression of debilitating diseases like Alzheimer's and Parkinson's. Several scientists interviewed by Reuters news agency pointed to mounting research supporting testing diabetes drugs against neurodegenerative diseases. Results are years away and success uncertain. But interest has been buoyed by recent positive data on Alzheimer's drugs developed by Eisai with partner Biogen and by Eli Lilly demonstrating that removing sticky amyloid plaques accumulated in the brain can slow cognition decline caused by the fatal mind-wasting disease. Those successes followed decades of futility that had left many questioning the validity of the amyloid theory behind most experimental Alzheimer's drugs.

Japanese pharmaceutical firm Eisai Co plans to seek full approval of its experimental Alzheimer's drug lecanemab in the United States, Europe and Japan armed with data showing it can slow the brain-wasting disease for people with early symptoms, potentially getting the treatment to patients next year. It remains unclear how widely the drug developed with U.S. biotech Biogen Inc will be used due to uncertainty over insurance coverage, including the U.S. government's Medicare plan for people age 65 and over, potential side effects and cost. One Wall Street analyst told Reuters news agency that he is not counting on measurable sales until 2024. Several estimated lecanemab may be priced at around $20,000 per year. "Most people who this (drug) would apply to are on Medicare, and most private payers look to Medicare as they make their own (coverage) decisions. So there's a massive roadblock in the way of all who could benefit from this treatment," said Robert Egge, Alzheimer's Association chief public policy officer. Eisai confirmed on Tuesday (November 30) that lecanemab - an antibody designed to remove sticky deposits of a protein called amyloid beta from the brain - reduced the rate of cognitive decline on a clinical dementia scale by 27% compared to a placebo. It also gave new details on side effects including a dangerous type of brain swelling and brain bleeding.

In a new study, men who took phosphodiesterase type 5 inhibitors (PDE5Is), such as Viagra (sildenafil; Pfizer), for treatment of erectile dysfunction, were found to be 18 per cent less likely to develop Alzheimer's compared to those who did not take the drugs. The results of the population-based cohort study were published in Neurology on 7 February 2024. Researchers at University of Oxford examined IQVIA Medical Research Data UK records of 269,725 men, who were diagnosed with erectile dysfunction between January 2000 and March 2017. None of the participants had any memory or thinking problems at the start of the study and they were followed for an average of 5.1 years. During the study, 749 out of 1,119 participants taking erectile dysfunction drugs developed Alzheimer's disease.

The first big breakthrough in 30 years of Alzheimer's research is providing momentum for clinical trials of "cocktail" treatments targeting the two hallmark proteins associated with the mind-robbing disease, according to interviews with researchers and pharmaceutical executives. Drugmakers Eisai and Biogen reported in September that their therapy lecanemab could slow progress of the disease by 27% over 18 months compared with a placebo. The finding validates the theory that clearing the amyloid protein that forms clumps in the brains of Alzheimer's patients could slow or halt the disease and has strengthened the support from some scientists for simultaneously targeting another notorious protein linked to Alzheimer's: tau. Eisai and Biogen are scheduled to present full data from their lecanemab study on Tuesday at the Clinical Trials on Alzheimer's Disease conference in San Francisco. The U.S. Food and Drug Administration is expected to make a decision by early January on the companies' application for accelerated approval. If approved on an accelerated basis, the companies said they would immediately apply for full U.S. regulatory approval which could help secure Medicare coverage.

Early detection and treatment of Alzheimer's disease require the use of dependable and cost-effective screening technologies. Researchers at Sweden's Karolinska Institutet have revealed that the level of tau, a protein that plays a vital role in the development of severe dementia, is associated with a kind of sugar molecule in the blood. The study, which is published in Alzheimer's & Dementia, can pave the way for a simple screening procedure able to predict onset ten years in advance. "The role of glycans, structures made up of sugar molecules, is a relatively unexplored field in dementia research," says the study's first author Robin Zhou, medical student and affiliated researcher at the Department of Neurobiology, Care Sciences and Society (NVS), Karolinska Institutet. "We demonstrate in our study that blood levels of glycans are altered early during the development of the disease. This could mean that we'll be able to predict the risk of Alzheimer's disease with only a blood test and a memory test." In Alzheimer's disease, the neurons of the brain die, which is thought to be a result of the abnormal accumulation of the proteins amyloid beta and tau. Clinical trials for Alzheimer's drugs show that treatment should commence early in the pathological process, before too many neurons have died, to reverse the process before it is too late.