生物医药公司Keryx开发的治疗高磷酸盐血药物Zerenex(ferric citrate coordination complex,枸橼酸铁复合物)在最近一项治疗肾脏透析患者的临床三期研究中达到了其预期目标。这一结果也将有助于说服FDA最终批准Zerenex(ferric citrate coordination complex,枸橼酸铁复合物)上市。Zerenex主要用于治疗高磷酸盐血症，这种疾病常见于患有慢性肾病的患者。在此次有441人参与的临床三期研究中，Zerenex治疗组相对于对照组血液中磷酸盐含量明显降低，具有统计学差异。这一结果也被发表在Journal of the American Society of Nephrology。
这项序贯随机对照研究，共招募了441例需要透析的患者，随机分配到Zerenex组和活性对照组（开始4周为安慰剂），共进行52周的临床研究。主要终点比较Zerenex和安慰剂对血磷水平的改变。同时，观察血清ferritin，饱和转铁蛋白等指标。研究发现,与安慰剂相比，枸橼酸铁复合物平均降低血磷水平为-2.2±0.2 mg/dl (mean±SEM) (P<0.001)
目前Keryx正在等待FDA就Zerenex做出最后的决定，FDA将于今年9月7日前宣布是否批准Zerenex上市。而据目前估计这一市场高达24亿美元。与这一庞大市场相对应的是，分析人士并不看好Zerenex在这一市场能分上一块蛋糕。原因是赛诺菲的 Renvela 和 Shire的Fosrenol都已经失去了专利保护，最近一段时间许多同类生物仿制药都会登陆市场。因此Zerenex将面临来自仿制药的激烈竞争。
New Drugs Online Report for ferric citrate coordination complex
Information
Generic Name: ferric citrate coordination complex
Trade Name: Fexeric (EU), Auryxia (US)
Synonym: Zerenex
Entry Type: New molecular entity
Development and Regulatory status
UK: Approved (Licensed)
EU: Approved (Licensed)
US: Launched
UK launch Plans: Available only to registered users
Actual UK launch date:
Comments
Mar 16: Based on the study of patients who had not adequately responded to or were unable to tolerate current oral iron therapies, Keryx said it would apply in Q3 2016 for an expanded approval with U.S. regulators for ferric citrate in moderate to advanced chronic kidney patients not dependent on dialysis [14].
30/03/2016 09:19:07
Auryxia was launched in the US in Dec 14 [13].
25/09/2015 11:00:33
Sep 15: Keryx is working with potential partners regarding commercialisation in the EU, and expect to finalise their commercial strategy by end 2015 [13].
25/09/2015 10:58:43
Sep 15: European Commission approves Fexeric® for control of hyperphosphatemia in adults with CKD, including both dialysis and pre-dialysis patients [13].
25/09/2015 10:57:49
Jul 15: EU positive opinion for control of hyperphosphataemia in adults with CKD [12].
24/07/2015 12:45:40
Sept 14: US regulators warn about danger of iron overload with ferric citrate and that doctors must monitor iron parameters. Pharma company argue that this could reduce the use of IV iron therapy though. [11]
08/09/2014 10:38:18
Sept 14: Approved by US FDA for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis. [10]
08/09/2014 09:20:28
Mar 14: Filed in the EU as a treatment for hyperphosphataemia in patients with chronic kidney disease (both dialysis- and non-dialysis dependent) [8].
12/03/2014 09:59:30
Aug 13: Filed in the US for the treatment of elevated serum phosphorus levels, or hyperphosphataemia, in patients with CKD on dialysis. An EU filing is also planned [7].
12/08/2013 12:22:17
May 11: EMA have indicated PIII US trial programme will be sufficient for EU application [1].
04/05/2011 10:52:41
Trial or other data
Mar 16: Keryx announces ferric citrate met the goals of a late stage clinical trial to treat iron deficiency anemia in chronic kidney disease patients not yet requiring dialysis , potentially paving the way for an expanded approval of the treatment. In the 16-week study of 234 patients with moderate to severe kidney disease |
