日前，美国食品药品管理局（FDA）批准了Vifor Fresenius Medical Care Renal 制药公司的高磷血症药物Velphoro。Velphoro(Sucroferric Oxyhydroxide)之前也叫作PA21，该药物的获批基于III期临床试验数据，数据证明这款药物可成功控制血液中磷的蓄积，并且与目前慢性肾病透析患者的标准治疗药物即赛诺菲旗下的Renvela相比，其用药负担更低。
透析患者平均每天要服用19片药物，而这些药物中磷酸盐结合剂能占到大约50%。Velphoro所推荐的起始用药剂量是每天三片（即每餐一片），所以这款药物的依从性提高了很多。该制药公司董事长Charles DeLoach对PharmaTimes说，除了减少服用剂量，该公司还请求一家瑞士大学进行相关试验以达到适当的平衡，使药片足够硬以保持其完整性，但药片也要软到可以轻易地咀嚼，这也是大多数透析患者所面临的一个问题。
DeLoach指出，该公司也在透析患者（他们中的许多人味蕾发生了变化）中进行广泛的口味试验，目前为止，所有口味试验中最令人满意的是野莓味。“当你给患者的东西尝起来很好而容易服用时，那他们服药的几率会高很多”。
Velphoro由Vifor制药开发，其所有权利在2011年被转移给了Vifor Fresenius Medical Care Renal制药。这款药物将于2014年由费森尤斯医疗北美公司在美国投放市场。DeLoach先生告诉PharmaTimes说，费森尤斯医疗北美公司在铁缺乏治疗药物蔗糖铁促销方面已取得了非凡的成就，我们很自信他们会在Velphoro上复制这一成功。该公司指出，这款药物在欧洲、瑞士及新加坡的上市申报工作正在进行当中，审批决定预计会在2014年上半年获得。进一步的申报资料提交工作正在准备当中。
Velphoro (sucroferric oxyhydroxide) Chewable Tablet
Company: Vifor Fresenius Medical Care Renal Pharma France
Application No.: 205109
Approval Date: 11/27/2013
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
Indication
Velphoro® (sucroferric oxyhydroxide) is a phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.
Important Safety Information
Velphoro must be administered with meals. Velphoro tablets must be chewed and not swallowed whole. To aid with chewing and swallowing, the tablets may be crushed.
Patients with peritonitis during peritoneal dialysis, significant gastric or hepatic disorders, following major gastrointestinal (GI) surgery, or with a history of hemochromatosis or other diseases with iron accumulation have not been included in clinical studies with Velphoro. Monitor effect and iron homeostasis in such patients.
In a parallel design, fixed-dose study of 6 weeks duration, the most common adverse drug reactions to Velphoro chewable tablets in hemodialysis patients included discolored feces (12%) and diarrhea (6%).
Velphoro can be administered concomitantly with ciprofloxacin, digoxin, enalapril, furosemide, HMG‑CoA reductase inhibitors, hydrochlorothiazide, losartan, metformin, metoprolol, nifedipine, omeprazole, quinidine and warfarin. Take alendronate and doxycycline at least 1 hour before Velphoro. Velphoro should not be prescribed with oral levothyroxine and oral vitamin D analogs.
For additional important safety information, please see the full Prescribing Information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, call 1-800-FDA-1088, or call Fresenius Medical Care at 1-800-323-5188.
This information is intended for use by US Healthcare Professionals only.
References: 1. Velphoro [package insert]. Waltham, MA: Fresenius Medical Care North America. Rev. 12/2013. 2. Chiu YW, et al. Pill burden, adherence, hyperphosphatemia, and quality of life in maintenance dialysis patients. Clin J Am Soc Nephrol. 2009;4(6):1089–1096. 3. Wang S, et al. Serum phosphorus levels and pill burden are inversely associated with adherence in patients on hemodialysis. Nephrol Dial Transplant. 2013 Sep 5. [Epub ahead of print]. 4. Tonelli M, et al. Oral phosphate binders in patients with kidney failure. NEJM. 2010;362:1312–1324. 5. US-DOPPS Practice Monitor, October 2013; http://www.dopps.org/DPM/. 6. Floege J et al. Efficacy and safety of an iron-based phosphate binder, PA21, in hyperphosphatemic CKD patients on dialysis. Poster SA-PO1103 presented at: ASN Congress 2012, San Diego.
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New Drugs Online Report for sucroferric oxyhydroxide
Information
Generic Name: sucroferric oxyhydroxide
Trade Name: Velphoro
Synonym: ferrihydrite
Entry Type: New molecular entity
Developmental Status
UK: Approved (Licensed)
EU: Approved (Licensed)
US: Launched
UK launch Plans: Available only to registered users
Actual UK launch date:
Comments
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, & eva luated 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 eva luations
EPAR http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002705/WC500175257.pd
