Dementia due to Alzheimer's disease (disorder)

A new Alzheimer's treatment, donanemab, has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA), but a draft decision by the National Institute for Health and Care Excellence (NICE) has rejected the drug for use on the NHS. Manufactured by Eli Lilly, donanemab, also known as Kisunla, is designed to slow cognitive decline in patients with early-stage Alzheimer’s disease by targeting beta-amyloid plaques in the brain, a known cause of the condition. The decision from NICE, published today (23 October 2024), has sparked frustration within the Alzheimer’s community, especially following NICE's similar rejection of another Alzheimer’s drug, lecanemab, just months earlier. While both treatments represent a breakthrough in addressing the disease's underlying cause rather than just managing symptoms, NICE determined that donanemab does not currently demonstrate sufficient value for NHS use due to its high costs and limited benefits. According to NICE's independent committee, clinical evidence showed that donanemab could slow the progression of Alzheimer’s disease by 4 to 7 months. However, the cost-effectiveness estimate for the drug was found to be five to six times higher than what NICE typically considers acceptable. Helen Knight, director of medicines evaluation at NICE, stated, “While the drug offers some benefit, this is just not enough to justify the significant cost to the NHS.” She emphasized that the draft decision could be revisited pending further evidence from Eli Lilly and NHS England. googletag.cmd.push(function () { googletag.display('text-ad1'); }); Despite the MHRA’s approval, NICE raised concerns over the drug’s safety profile, as 33% of trial participants experienced amyloid-related imaging abnormalities (ARIA), including brain swelling and bleeding. The treatment also requires monthly hospital infusions and intensive monitoring, adding to the costs. With an estimated 70,000 patients in England eligible for the treatment, the financial strain on the NHS was a critical factor in NICE’s rejection. Alzheimer's Society - mixed emotions The UK’s leading dementia charity, Alzheimer’s Society, responded to the news with mixed emotions. While celebrating the MHRA’s approval, the charity expressed disappointment with NICE’s draft guidance. Professor Fiona Carragher, Chief Policy and Research Officer at Alzheimer’s Society, remarked, “Disease-modifying therapies like donanemab and lecanemab offer a new horizon of hope in the fight against dementia. However, we respect NICE's decision and hope to see improvements in the affordability and efficacy of treatments over time, as we have seen in other diseases like cancer.” Alzheimer’s Society funded the research that identified the role of amyloid plaques 30 years ago, laying the groundwork for today’s treatment developments. The charity continues to advocate for better access to treatments and early diagnosis, highlighting that more than a million people live with dementia in the UK, many without a diagnosis. Professor Carragher emphasized, “New treatments are only one part of the solution. We must ensure that people with dementia have access to timely and accurate diagnosis so they can benefit from the treatments available now and in the future.” As the landscape for Alzheimer’s disease treatment evolves, NICE has announced that it is monitoring around 27 new products in the pipeline. The organization also plans to revisit its suite of guidance on Alzheimer’s care and diagnostics, including researching blood biomarkers for earlier and more accurate detection. The consultation period for NICE’s draft guidance on donanemab will run until 20 November 2024, during which further evidence and responses will be reviewed. A final decision on donanemab’s NHS availability is expected in the coming months. Meanwhile, the Alzheimer’s community continues to await the final recommendations for lecanemab, with its second committee meeting scheduled for November 2024.

【招商】安徽普利原料药盐酸美金刚国内获批上市，期待与您合作，共赢未来        海南普利制药股份有限公司（以下简称“普利制药”）子公司安徽普利药业有限公司（以下简称“安徽普利”）于近日收到国家药品监督管理局(以下简称“NMPA”）签发的盐酸美金刚化学原料药上市申请批准通知书。 本次上市申请获批，表明安徽普利盐酸美金刚原料药产品已实现商业化生产、注册报批成功转A,可关联国内下游制剂，产品稳定且持续供应全球客户。 1、产品基本情况 （一）药品名称：盐酸美金刚 （二）剂型：原料药 （三）登记号：Y20230000102 （四）包装规格：15kg/桶 （五）持有人：安徽普利药业有限公司 2、制剂产品情况       盐酸美金刚（Memantine Hydrochloride）为新型N-甲基-D-天冬氨酸（NMDA）受体拮抗剂，作用机制独特，具有保护神经细胞功能以及促进认知功能恢复的作用。适用于中重度至重度阿尔茨海默型痴呆，可改善患者的认知功能障碍。       由Merz、灵北制药（Lundbeck）和森林实验室（Forest）共同研发，最早于2002年5月15日获欧洲药物管理局（EMA）批准上市，之后于2003年10月16日获美国食品药品管理局（FDA）批准，后又于2011年1月21日获日本医药品医疗器械综合机构（PMDA)批准上市，由灵北公司在欧洲上市销售，商品名为Ebixa，美国地区则由森林实验室上市销售，商品名为Namenda。       目前国际阿尔茨海默病指南已推荐NMDA受体拮抗剂为阿尔兹海默症的一线治疗药物。是FDA批准的第一个用于中重度痴呆治疗的药物。作为目前唯一可用于治疗中至重度AD的NMDA受体拮抗剂，盐酸美金刚担当抗AD的重任。 3、市场情况       根据IMS数据库显示， 盐酸美金刚2023年全球制剂的销售额6.9亿美元，2023年全球原料药消耗量33吨。       从2023年全球制剂市场占比来看，主要销售市场在西班牙、日本、美国、巴西、德国、俄罗斯、墨西哥、阿根廷、韩国、意大利、中国等。安徽普利此品种原料药已经在美国市场进行DMF原料药备案/登记，“状态为A”，国内亦已获批，“状态为A”，已拿到两大市场的准入资格，欧洲市场的注册工作也在有序推进中。       米内网数据库显示，盐酸美金刚2023年中国销售额2.3亿人民币，药智网数据库显示，2023年国内原料药消耗量为1.2吨。 4、产品优势 1）产品纯度在99.9%以上，产品质量优，稳定性高； 2）成品中各项指标均超过ChP、USP质量要求； 3）粒径可根据客户需求定制； 4）有专用生产线，可以稳定供货。 5、注册法规优势 本品已在中美等市场进行原料药备案/登记， ①   其中US DMF号为037704 （状态：A ）， ②  CN登记号为Y20230000102，(状态: A ），其他市场的注册工作也在持续推进中。 欧洲市场的注册登记工作也在有序推进中。  安徽普利        安徽普利药业有限公司，成立于2018年，坐落于安庆国家高新技术产业开发区。是一家活性原料专业供应商，向全球医药、保健和护肤领域提供化学合成、生物合成的高品质特色原料。                     安徽普利目前拥有3个符合欧美中GMP标准的API 生产车间、10条生产线，357台多功能设备。拥有强大高效的研发和生产团队、配备现代化生产设施、建立严格地欧美高端原料药cGMP质量体系和高标准EHS体系，为客户提供高品质原料药和中间体的同时，也提供CDMO、工艺技改等服务。        依托强大的研发能力和技术转化能力，目前公司已完成造影剂（钆特酸葡胺、钆特醇、钆布醇、碘美普尔、碘普罗胺、碘佛醇、碘帕醇、碘克沙醇等）、合成生物学（依克多因、红景天苷）、抗肿瘤（环磷酰胺）、其他原料药（氢氧化镁、阿普斯特、克立硼罗、伏立康唑、盐酸美金刚）、其他药用辅料（DOTA、磺丁基-β-环糊精钠、卡特利多钙、考布曲钙）等系列产品的研发与生产。      盐酸美金刚是普利布局高端AD领域品种之一，产品具有广阔的市场前景。该产品的获批，标志着普利制药在此领域中又迈出了坚实的一步，对公司拓展市场带来积极影响。 欢迎垂询、欢迎合作！ Welcome for enquiry, cooperation！ 联系人：聂先生 Liangdeng Nie 电话：18857693467 邮箱：nieliangdeng@hnpoly.com 联系人：薛女士 Faye Xue 电话：13616530509 邮箱：ff@hnpoly.com

MapAI uses natural-language-processing-based generative AI to initiate an analysis of Komodo’s Healthcare Map, made up of de-identified data on more than 330 million patient interactions. Komodo Health continues to invest in generative AI capabilities, seeing the potential to use AI-powered conversational language to make it easier for health research teams to parse through troves of data.The health data company rolled out a new AI analytics assistant, MapAI, as part of its overarching platform MapLab.MapAI and another new tool, MapExplorer, enable healthcare professionals to explore any therapeutic area simply by asking questions in plain language, according to Laurent Bride, Komodo Health's chief technology officer.MapAI uses natural-language-processing-based generative AI to initiate an analysis of Komodo’s Healthcare Map, made up of de-identified data on more than 330 million patient interactions within the healthcare system. The no-code ChatGPT-like tool enables health research teams, even individuals with no coding experience, to rapidly evaluate drug trends, track how diseases spread and evaluate how patients are being treated, according to the company.The offering supports faster decision-making by enabling users at any skill level or experience with healthcare data to use conversational language to get clear answers to complex analytic questions in minutes versus hours or days, Komodo Health executives said. Komodos’s MapAI application allows users to ask healthcare-related questions using conversational language—reducing the need to pull in data experts for early-stage analyses. Research teams can ask questions like, "What is the patient breakdown of GLP-1 prescriptions by payer?" or "How many patients with a history of dementia were diagnosed with Alzheimer's in 2023?” "For AI to truly deliver value in healthcare, a robust data foundation is essential—and that’s where Komodo’s MapAI, our latest GenAI solution, powered by our Healthcare map shines," Bride said. "Over the past decade, we've built a range of tools designed to meet users wherever they are, providing the right experiences—whether they need no-code, low-code or high-code solutions. This approach has enabled a suite of analytics that empowers life sciences, payers, providers and developers to generate and scale critical insights efficiently."Komodo Health customers often express frustration over the time spent preparing data for analysis, Bride noted."They crave streamlined tools that not only simplify processes but also eliminate the need for multiple-point solutions. With these new capabilities, we’re paving the way for healthcare companies to collaborate more effectively, navigate market complexities, mitigate risks, and make data-driven decisions that drive both immediate and long-term success. And this is just the beginning of the innovations we’ll be rolling out this year," he said.Insights gleaned from MapAI can be easily transferred into MapView, Komodo’s no-code application on the MapLab platform, featuring pre-built analytic modules for market and disease landscaping, patient and healthcare provider segmentation and brand performance monitoring.A 2024 survey from Frost & Sullivan found that healthcare companies spend an average of seven months gathering data into a usable state. New generative-AI-powered tools propose to be accelerants for decision-making within healthcare and life sciences organizations. They give anyone within an enterprise—regardless of their experience working with healthcare data—the ability to produce the type of net-new insights needed for critical business decisions, Komodo Health executives said. MapAI significantly cuts down time to insights and allows users to more quickly test and iterate hypotheses before initiating deeper, costly analyses. It marks the newest addition to the MapLab platform and is launching alongside another new, AI-enabled tool called MapExplorer. That solution is designed for companies that are new to the Healthcare Map but want to access its capabilities, equipping teams with point-and-click functionality and conversational AI features, according to the company.Komodo Health also recently announced it was integrating Cornerstone AI's software into components of its MapEnhance offering. MapEnhance, first unveiled in 2023, features a library of specialty data sets from Komodo and its partners. The move to integrate with Cornerstone AI follows a successful pilot program in which Cornerstone's proprietary algorithms strengthened the fidelity of Komodo's Lab Results, a product available within MapEnhance, the companies said.Komodo claims its suite of products, including MapLab, is currently being used by over 200 life sciences and healthcare organizations, including Johnson & Johnson, Merck, Novo Nordisk, MoonLake Immunotherapeutics, Regeneron and Takeda Pharmaceuticals.Launched in 2014 by co-founders Web Sun and Arif Nathoo, M.D., the company has raised $514 million to date, including a $220 million series E round in 2021 and a structured equity infusion of $200 million in November 2022.