| 2013年11月30日，Vifor制药的磷酸盐结合剂Velphoro（sucroferric oxyhydroxide）已获FDA批准，用于治疗慢性肾脏病（CKD）透析患者的高磷血症（hyperphosphatemia），以控制其血清磷水平。 Velphoro（以前称为PA21）是一种铁基（iron-based）、无钙、可咀嚼的磷酸盐结合剂，该药的获批，为接受透析治疗的慢性肾脏病（CKD）患者控制其血清磷水平提供了一种新的有效的治疗选择，该药将于2014年在美国上市。 Velphoro的获批，是基于一项关键性III期临床试验的结果。该项研究在正接受透析治疗的慢性肾脏病（CKD）患者中开展，研究结果表明，与标准的护理药物碳酸司维拉姆（sevelamer carbonate）相比，Velphoro以较少的药丸数量，成功地控制了患者的高磷血症，52周后，用于控制高磷血症的平均每天剂量仅为3.3粒/天，达到了研究的主要和次要终点。 高磷血症（hyperphosphatemia）是指血液中磷水平的异常升高，是正在接受透析治疗的慢性肾脏病（CKD）患者中一种常见且严重的疾病。大多数透析患者需接受磷酸盐结合剂治疗。 然而，尽管目前已有多种不同的磷酸盐结合剂可用，但高达50%的患者仍无法达到并维持其目标血清磷水平。在一些患者中，因高的服药负担导致的非依从性（non-compliance）和较差的耐受性，似乎是导致血清磷水平控制不足的关键因素。平均而言，透析患者每天需服约19粒药物，而磷酸盐结合剂占到了其中的约50%。而Velphoro的推荐起始剂量仅为每日3片（每餐1片）。 目前，Velphoro在欧盟、瑞士、新加坡的监管审查正在进行中，预计将于2014年上半年得出审查决定。进一步的监管申请正在准备中。 Velphoro Generic Name: sucroferric oxyhydroxide (SOO kroe FER ik OX ee hye DROX ide) Brand Names: Velphoro ----------------------------------- New Drugs Online Report for sucroferric oxyhydroxide Information Generic Name: sucroferric oxyhydroxide Trade Name: Velphoro Synonym: ferrihydrite Entry Type: New molecular entity Development and Regulatory status UK: Launched EU: Launched US: Launched UK launch Plans: Available only to registered users Actual UK launch date: January 2015 Comments Jan 15: Launched in UK as Velphoro for hyperphosphataemia in dialysis. Price: 500mg tablets, 90 = £175.00 [8] 20/01/2015 16:35:36 Aug 14: Approved in the EU [7]. 27/08/2014 12:15:20 Mar 14: Launched in the US [7]. 27/08/2014 12:15:03 Jun 14: EU positive opinion for Velphoro for the control of serum phosphorus levels in patients with end-stage renal disease [6]. 27/06/2014 12:37:10 Nov 13: Approved in the US for control of serum phosphorus levels in patients with CKD on dialysis. Velphoro will be launched in the US by Fresenius Medical Care North America in 2014 [5]. 30/05/2014 16:15:14 Ferrihydrite has been filed in the EU via the centralised procedure [3]. 12/03/2013 11:58:49 Feb 13: Filed in the US [1]. 12/03/2013 11:31:25 Dec 12: Filed in the EU [1]. 12/03/2013 11:31:09 Trial or other data The pn‑FeO(OH) moiety of PA21 (active ingredient) possesses a high phosphate adsorption capacity with minimal iron [3]. 12/03/2013 11:57:07 Dec 12: A 28-week safety extension trial (NCT01464190) completes enrolment of 940 pts in the US [1]. 12/03/2013 11:37:27 Jul 12: Topline results reported for the open-label pivotal PIII (NCT01324128) trial. Both primary & secondary endpoints were met in 1,059 pts with CKD receiving dialysis. The trial enrolled pts in the US, the EU, South Africa, Russia & Ukraine, & evaluated maintenance doses of PA 21 vs. sevelamer carbonate or inactive low doses of PA 21, in the treatment of hyperphosphataemia. These results form the basis of regulatory filings in the US, EU & Switzerland [1]. 12/03/2013 11:36:52 Mar 10: PII (NCT00824460) trial to assess the ability of PA 21 to lower serum phosphate levels & determine its tolerability in pts with CKD on maintenance haemodialysis completes. Pts were randomised to receive PA 21 (1.25, 5, 7.5, 10 or 12.5g) or sevelamer (Renagel®) as active control. The primary endpoint was met; doses of PA 21 were effective in reducing elevated serum phosphate. The trial enrolled 252 subjects in the US, the EU, Croatia, Switzerland & Russia [1]. 12/03/2013 11:33:55 Evidence Based Evaluations AWMSG http://www.awmsg.org/awmsgonline/app/appraisalinfo/1504 NICE ESNM http://www.nice.org.uk/advice/esnm51 EPAR http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002705/WC500175257.pdf References Available only to registered users Category BNF Category: Phosphate-binding agents (09.05.02.02) Pharmacology: Polynuclear iron (III) oxyhydroxide phosphate binder - chewable tablet Epidemiology: Prevalence of CKD 4/5 is 1% or less in England (520,000 people). Nearly 26,000 are receiving dialysis [2]. Almost all pts with CKD 5 have hyperphosphataemia [4]. Indication: Hyperphosphataemia Additional Details: in patients with end-stage renal disease Method(s) of Administration Oral Company Information Name: Vifor Pharma US Name: Vifor Pharma Further Information Anticipated commissioning route (England) NHSE High cost drug list? No Implications Available only to registered users |
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FDA批准Velphoro治疗慢性肾脏病透析患者高磷血症简介：
2013年11月30日，Vifor制药的磷酸盐结合剂Velphoro（sucroferric oxyhydroxide）已获FDA批准，用于治疗慢性肾脏病（CKD）透析患者的高磷血症（hyperphosphatemia），以控制其血清磷水平。Velphoro（以前称 ... 责任编辑：admin
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