NICE放宽立场，支持CSL Vifor的IgAN药物NICE relents and backs drug for IgAN from CSL Vifor

动脉网2025-05-23

Thousands of people living with a rare form of chronic kidney disease (CKD) in the UK will soon be able to access a new oral treatment – CSL Vifor's Filspari – that can help slow down the decline in ...

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Filspari, an endothelin-1 and angiotensin IIIgAN发生在抗体在肾脏中积累，导致炎症和瘢痕形成，可能发展为严重的慢性肾病和肾衰竭。","collect":0,"end_time":0,"defaultTopTitle":"qq.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"BK4543":"AI","LU1169590202.USD":"ALLSPRING (LUX)  U.S. SELECT EQUITY \"I\" (USD) ACC","SG9999004303.SGD":"Nikko AM Shenton Global Opportunities SGD","LU0728928796.USD":"abrdn SICAV I - GLOBAL SMALL&MID-CAP SDG HORIZONS EQUITY \"A\" (USD) ACC","SGXZ23171101.USD":"NIKKO AM SHENTON GLOBAL OPPORTUNITIES (USD) ACC","BK4566":"资本集团","IE00BFMHRM44.USD":"NEUBERGER BERMAN GLOBAL EQUITY MEGATRENDS \"A\" (USD) ACC","LU1169589451.USD":"ALLSPRING (LUX)  U.S. SELECT EQUITY \"A\" (USD) ACC","BK4086":"建筑产品","BK4023":"应用软件","NICE":"NICE系统","CSL":"卡莱尔伙伴"},"translate_title":"NICE relaxes stance in favor of CSL Vifor's IgAN drug NICE relents and backs drug for IgAN from CSL Vifor","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"NICE":1,"CSL":1},"content_text":"Thousands of people living with a rare form of chronic kidney disease (CKD) in the UK will soon be able to access a new oral treatment – CSL Vifor's Filspari – that can help slow down the decline in their kidney function.英国成千上万名患有罕见慢性肾病（CKD）的患者将很快能够获得一种新的口服治疗药物——CSL Vifor公司的Filspari——这种药物可以帮助减缓他们肾功能的衰退。Final终局draft guidance草案指南from NICE has backed NHS use of Filspari (sparsentan) for primary immunoglobulin A nephropathy (IgAN), also known as Berger's disease, just a few weeks after it was it was turned down by the health technology assessment (HTA) agency.来自NICE的支持NHS使用Filspari（sparsentan）治疗原发性免疫球蛋白A肾病（IgAN），也称为Berger病，就在几周前它还被卫生技术评估（HTA）机构拒绝。NICE estimates that around 4,200 people could be eligible for treatment with the drug, which is recommended for use in adults with a urine protein excretion of 1.0g/day or more, or a urine protein-to-creatinine ratio of at least 0.75g/g.NICE 估计，大约有 4,200 人可能符合使用该药物的条件，该药物被推荐用于尿蛋白排泄量为每天 1.0 克或以上，或尿蛋白与肌酐比值至少为 0.75 克/克的成人。IgAN occurs when antibodies accumulate in the kidneys, causing inflammation and scarring, and can develop into serious CKD and kidney failure. Filspari, an endothelin-1 and angiotensin IIIgAN发生在抗体在肾脏中积累，导致炎症和瘢痕形成，可能发展为严重的慢性肾病（CKD）和肾衰竭。Filspari是一种内皮素-1和血管紧张素II。inhibitor, has been shown in clinical trials to reduce levels of protein in the urine (proteinuria), a biomarker for disease activity, and slow down the progression of kidney damage.抑制剂在临床试验中已被证明能够减少尿液中的蛋白质水平（蛋白尿），这是疾病活动的生物标志物，并减缓肾脏损伤的进展。In March – ahead of Filspari's approval in the UK the following month – NICE recommended against approval, saying that while the data on proteinuria was clear, it was less certain whether Filspari maintained kidney function better than current treatment, which includes generic angiotensin-2 receptor blockers such as irbesartan..今年 3 月——在 Filspari 获得英国下月批准之前——英国国家卫生与临床优化研究所 (NICE) 建议不予批准，称尽管有关蛋白尿的数据明确，但尚不确定 Filspari 在维持肾功能方面是否比现有治疗（包括氯沙坦等通用血管紧张素-2 受体阻滞剂）更具优势。Its change of heart follows a public consultation period in which NICE's appraisal committee 'heard about the devastating impact this disease can have on people's ability to work, travel, and maintain relationships and the limited treatment options available,' according to the agency's director of medicines evaluation, Helen Knight..根据该机构药品评估主任海伦·奈特的说法，其态度的转变是在一段公开征求意见期之后，期间NICE的评估委员会“听到了这种疾病对人们工作、旅行、维持人际关系能力可能造成的毁灭性影响，以及可用治疗方案的有限性”。The drug will help to reduce pressure on the NHS by preventing or delaying the number of people progressing to end-stage renal kidney disease, which could require dialysis or a kidney transplant, according to NICE.根据NICE的说法，该药物将通过预防或延缓人们进展为终末期肾病（可能需要透析或肾移植）的数量，帮助减轻对NHS的压力。The list price for Filspari is around £3,400 plus VAT for a 30-day supply of tablets, but CSL Vifor is supplying the drug to the NHS at a confidential discount. Now that the final draft guidance is published, it will be funded in England within 90 days of the final version, which is expected to be published on 27th June..Filspari 的标价约为 3,400 英镑（另加增值税），可供应 30 天的片剂，但 CSL Vifor 正在以保密折扣向 NHS 提供该药物。由于最终草案指南现已发布，预计最终版本将在 6 月 27 日发布，届时英格兰将在最终版本发布后的 90 天内获得资金支持。CSL Vifor said it expects to launch sparsentan in the UK in the second half of the year, with commercial stock available from July.CSL Vifor 表示，预计将在今年下半年在英国推出 sparsentan，7 月起将有商业库存可供使用。'IgAN has few symptoms at the early stages so is often not diagnosed until the condition has significantly progressed,' commented Fiona Loud, policy director at Kidney Care UK.“ IgAN 在早期几乎没有症状，因此通常在病情显著进展之前无法诊断出来，”英国肾脏护理组织政策总监 Fiona Loud 评论道。'This guidance adds a further treatment that can slow the progression of the disease and so is a welcome announcement which will benefit many of the people with the condition in the UK.'“该指南增加了另一种可以减缓疾病进展的治疗方法，因此这是一个令人欢迎的公告，将使英国许多患有此病的人受益。”Photo by照片由Sasun Bughdaryan萨孙·布加里扬on打开UnsplashUnsplash","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":false,"tenantId":"TBCN","deviceId":"web-server-community-laohu8-v3","version":"4.42.3","shortVersion":"4.42.3","platform":"web","vendor":"web","appName":"laohu8","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2537870961","isCrawlerRequest":true}