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首页 » 罗氏要哭了!拜耳眼科药Eylea穷追不舍,斩获FDA第四个适应症

罗氏要哭了!拜耳眼科药Eylea穷追不舍,斩获FDA第四个适应症

来源:生物谷 2015-03-26 07:43

2015年3月26日讯 /生物谷BIOON/ --拜耳(Bayer)与合作伙伴再生元(Regeneron)近日收获大好消息,FDA已批准眼科药物Eylea(aflibercept,阿柏西普注射液)用于糖尿病性黄斑水肿(DME)患者糖尿病性视网膜病变(DR)的治疗,标志着Eylea在美国收获的第4个适应症。此前,该药已收获3个适应症,分别为湿性年龄相关性黄斑变性(wet-AMD)、视网膜静脉阻塞继发黄斑水肿(RVO-ME)、糖尿病性黄斑水肿(DME)。

目前,在眼科治疗领域,拜耳Eylea正与罗氏和诺华眼科药物Lucentis展开着激烈的的角逐。作为后起之秀的Eylea,尽管上市时间(2011年)比Lucentis(2006年)晚了近5年,但发展势头却异常迅猛,近年适应症及销售一再刷新,在2014年销售额已达到27.8亿美元,对Lucentis形成了严峻挑战。而根据去年10月公布的一项研究,Eylea治疗DME疗效击败Lucentis和Avastin,这使得Eylea在DME领域更具影响力。

另外,尽管Lucentis在上月中旬率先赢得FDA祝福,成为全球首个糖尿病性视网膜病变(DR)药物,但此次Eylea迅速跟进,收获DR适应症仅仅晚了一月而已。可以预见,双方将在DR领域再度展开一场恶斗。

需要指出的是,DR适应症也是Lucentis在美国的第4个适应症,该药其他3个适应症与Eylea相同,分别为:糖尿病性黄斑水肿(DME,2006年)、视网膜静脉阻塞继发黄斑水肿(RVO-ME,2010年)和湿性年龄相关性黄斑变性(wet-AMD,2012)。

Eylea是一种新型玻璃体内注射用VEGF抑制剂,是一种重组融合蛋白,由人体血管内皮细胞生长因子(VEFG)受体1和2的胞外区与人体免疫球蛋白G1的可结晶片段融合而成。Eylea作为VEGF家族各成员(包括VEGF-A)及胎盘生长因子(PIGF)的一种可溶性诱饵受体发挥作用,与这些因子具有极高的亲和力,从而抑制这些因子与同源VEGF受体的结合,因此Eylea可抑制异常的血管生成及渗漏。

目前,拜耳和Regeneron正在合作Eylea的全球开发。Regeneron保留Eylea在美国的独家权利,拜耳则授权获得该药在美国以外国家和地区的独家销售权,这2家公司将平分Eylea在未来销售的利润。((生物谷Bioon.com)

英文原文:U.S. FDA again expands usage of Regeneron eye drug Eylea

(Reuters) - U.S. health regulators on Wednesday approved Regeneron Pharmaceuticals Inc's big-selling eye drug Eylea to treat diabetic retinopathy, the most common diabetic eye disease and a leading cause of blindness in adults.

The Food and Drug Administration decision marked the fourth approval for Eylea, an injectable medicine sold in partnership with French drugmaker Sanofi. Eylea had sales of $2.78 billion in 2014.

"Today's approval gives patients with diabetic retinopathy and diabetic macular edema another therapy to treat this vision-impairing complication," Edward Cox, director of the FDA's Office of Antimicrobial Products, said in a statement.

Regeneron shares were down 2.4 percent at $461.90 on the Nasdaq by 11:10 a.m. EDT (1510 GMT) on an off day for biotech stock indexes.

The agency had previously approved Roche's rival drug Lucentis for diabetic retinopathy, a condition in which blood vessels in the eye swell and leak fluid, or in which abnormal new blood vessels grow, hampering vision.

Eyelea was initially approved for wet age-related macular degeneration, the leading cause of blindness in the elderly. It is also approved for diabetic macular edema and macular edema following retinal vein occlusion, all eyesight robbing conditions. (Reporting by Bill Berkrot; Editing by Alan Crosby)

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