FDA批准Alimera和iSivida糖尿病性黄斑囊样水肿药物Iluvien 发布日期:2014-09-30 来源:healio
FDA终于批准了Alimera和iSivida的糖尿病性黄斑囊样水肿药物Iluvien。
Following intravitreal injection using the pre-loaded device, patients treated with Iluvien must be monitored for raised intraocular pressure, vitreous haemorrhage and vitreous or retinal detachment.
虽然这个产品已经被欧盟的10个国家批准,并在英国和德国已经上市,但FDA已经3次拒绝它的上市申请,并一度要求再做两个三期临床实验确立Iluvien的疗效和安全性。这次批准的标签是已经接受一次激素治疗并且没有眼压上升的病人。Alimer的股票一度叫停,在收盘后交易上升27%。 糖尿病是波及3.6亿人的大疾病,糖尿病性黄斑囊样水肿是糖尿病失控的严重后果之一,是糖尿病人和中青年失明的主要原因。据估计美国有56万糖尿病性黄斑囊样水肿患者,现在主流疗法是激素和VEGF抗体,包括再生元的Eylea和基因泰克的Lucentis。Iluvien将和这类产品竞争。 Iluvien的活性成分是氟轻松,通过特殊装置植入眼底而缓释有效物质氟轻松。这个产品由iSivida研制,后被Alimera收购。今天的批准使iSivida得到2500万美元的里程金,iSivida还会得到20%的销售利润。Iluvien一次植入可持续给药3年,这比一月一次注射的VEGF抑制剂使用更方便。但由于一次植入可给药3年,如果出现不良反应比较麻烦。 另外这个产品预计8000美元一针,如果无效这一针下去也不能退货了,而只有约30%的病人对Iluvien应答。在无法预测应答人群的情况下,支付部门如何看待这8000美元的一针尚未可知。Iluvien有升高眼压和促生白内障的副作用,也可能成为医生和支付部门拒绝使用这个新产品的一个因素。专家估计Iluvien的市场吸收可能会比较缓慢。 Alimera和iSivida在欧洲的上市和销售都是单兵作战,没有和大药厂合作。在美国的上市申请更是一波三折,三度被FDA拒绝。FDA曾要求Alimera再做两个三期临床来准确定义Iluvien的价值,这近乎判处Iluvien死刑。虽然Iluvien已经在支付条件最严格的德国上市,并得到令各大药厂最为头疼的英国NICE的支持,但居然3次被FDA拒绝。 更为匪夷所思的是Alimera并没有做任何FDA要求的附加临床实验,而是花600万美元雇了一个职业报批公司重新组织和分析了已有数据,便得到FDA的首肯,说明Alimera在和药监部门打交道还经验欠缺。这令投资者怀疑其它方面如销售是否也存在不足之处。如果不和大药厂合作,Iluvien的上市和销售或许会重蹈ViVus减肥药Qysmia的覆辙。
FDA approves Iluvien for treatment of DME
The U.S. Food and Drug Administration has approved Iluvien for the treatment of diabetic macular edema in patients previously treated with corticosteroids who did not have a significant increase in IOP, Alimera Sciences announced in a press release.
Iluvien (fluocinolone acetonide implant 0.19 mg) was approved with no requirement that patients undergo cataract surgery, according to the release.
Pravin U. Dugel
The FDA approval was based on clinical trial data showing that by 24 months after implantation, 28.7% of patients had a 15-letter or greater improvement in best corrected visual acuity. Patients who received the implant had a significantly greater improvement in BCVA than control patients from 3 weeks to 36 months, according to the release. “The approval of Iluvien is wonderful news for the retinal community, as recent studies have indicated that as many as 50% of DME patients are not optimally managed with today’s standard of care known as anti-VEGF therapies,” Pravin U. Dugel, MD, an Alimera consultant and OSN Retina/Vitreous board member, said in the release. “Having a multi-year delivery, low-dose corticosteroid drug will provide an additional treatment option for patients with this disease.” Alimera expects to begin selling Iluvien in the U.S. during the first quarter of 2015, the release said. The company is scheduled to hold a conference call detailing the approval at 8:30 a.m. Eastern Time on Wednesday, Oct. 1. To participate in the event, call 877-369-6586 in the U.S. and Canada or 253-237-1165 internationally. A live webcast will be accessible on the Investor Relations section of the company website at www.alimerasciences.com.
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