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首页 » FDA信息 » FDA授予Shire重磅干眼病药物lifitegrast优先审查资格

FDA授予Shire重磅干眼病药物lifitegrast优先审查资格

来源:生物谷 2015-04-10 09:50

2015年4月9日讯 /生物谷BIOON/ --英国制药商Shire近日宣布,FDA已受理干眼病药物lifitegrast新药申请(NDA)并授予优先审查资格(PRD)。lifitegrast是一种实验性药物,旨在中断导致干眼症(dry eye)的免疫过程,该药开发用于干眼症成人患者的治疗。如果获批,lifitegrast有望成为可同时改善干眼病疾病症状和体征的首个药物。FDA已指定处方药用户收费法(PDUFA)目标日期为2015年10月25日。优先审查(PR)是FDA的一个新药审查通道,旨在加速开发及审查治疗严重的或危及生命的疾病的新药,保障在最短时间内为患者提供新的治疗选择。获得优先审查资格(PRD)的药物,FDA将给予加速审查并在8个月完成审查,而不是标准的12个月。lifitegrast NDA的提交,是基于在超过1800例患者中开展的4项临床试验的全部证据。包括一项II期研究,二项III期疗效和安全性研究,一项长期III期安全性研究。

lifitegrast是Shire计划在2020年实现年收入翻一番至100亿美元宏伟目标的关键药物,该药由Shire于2013年耗资1.6亿美元收购SARcode公司后获得。Shire对lifitegrast寄予厚望,认为该药的年销售峰值将达到10亿美元。除了lifitegrast,Shire对另一种治疗非酒精性脂肪性肝炎(NASH)的药物SHP626和一种治疗早产儿视网膜病变的蛋白替代疗法SHP607也寄予厚望。

不过,Shire的罕见病管线在本周四遭遇重大挫折,一种治疗Alagille综合征(ALGS,一种罕见肝脏疾病)的药物SHP625在关键II期临床失败,未能达到研究的主要和次要终点。该结果挫伤了业界对SHP625的乐观期待,并可能削弱Shire对SHP625和SHP626共计20亿美元销售峰值的期望值。

然而,投资者似乎对Shire的前景非常看好。尽管SHP625的II期临床失败让Shire股价下跌了近2%,但lifitegrast收获FDA优先审查资格的消息却使该公司股价回升了4%。目前,Shire正在稳步推进该公司有史以来最强的研发管线,共计21种药物处于临床开发。

值得一提的是,上个月,日本参天制药(Santen Pharma)研发的干眼症药物Ikervis(ciclosporin,环孢素)获欧盟批准,用于经人工泪液治疗为得到改善的干眼病成人患者严重角膜炎的治疗,成为欧洲上市的首个干眼病处方药。(相关阅读:喜讯!欧洲首个干眼病处方药Ikervis(环孢素)上市

关于lifitegrast干眼症:

lifitegrast是一种新型的小分子整合素抑制剂,可结合整合素LFA-1(淋巴细胞功能相关抗原-1),阻断LFA-1与同源配体ICAM-1(胞间粘附分子-1)的相互作用。LFA-1是存在于白细胞表面的一种蛋白。在干眼病中,ICAM-1在角膜和结膜组织中过量表达。LFA-1/ICAM-1相互作用促进免疫突触的形成,导致T细胞激活并迁移至目标组织。

干眼症(dry eye)又名角结膜干燥症(KCS),是指任何原因造成的泪液质或量异常或动力学异常,导致泪膜稳定性下降,并伴有眼部不适和(或)眼表组织病变特征的多种疾病的总称。它是目前最为常见的眼表疾病,主要治疗方法是使用人工泪液。(生物谷Bioon.com)

英文原文:Shire's billion-dollar eye drug gets in line for a speedy FDA review

Shire ($SHPG) picked up the FDA's promise of a fast review for its new dry eye drug, a treatment the company believes can eventually bring in more than $1 billion a year.

The drug, lifitegrast, is a small-molecule therapy designed to interrupt the immune process that leads to dry eye disease. The agency has accepted Shire's application, filed earlier this year, and enrolled lifitegrast into its priority review program, guaranteeing a truncated review and expecting to make a final decision on the drug by Oct. 25.

Lifitegrast is a key cog in Shire's plan to effectively double its annual sales to $10 billion by 2020, and the drug, acquired in the company's $160 million buyout of SARcode Bioscience in 2013, has the potential to bring in $1 billion a year on its own, according to management. Behind lifitegrast, Shire is expecting big things from SHP626, a treatment for non-alcoholic steatohepatitis (NASH), and SHP607, a protein-replacement therapy for the rare retinopathy of prematurity.

But Shire's pipeline bluster took a blow on Thursday when the company revealed SHP625, a liver disease drug acquired in its $260 million Lumena Pharmaceuticals buyout, failed to meet its primary and secondary goals in a Phase II study. The results dampened analysts' optimism for the program and may dent Shire's projection of reaping $2 billion peak sales from SHP625 and SHP626 combined.

Investors, however, appear to be bullish on Shire's prospects on the whole. SHP625's Phase II failure sent the Big Biotech's shares down about 2% on Thursday morning, but the afternoon news of lifitegrast's priority review sent them up 4% on the day.

Meanwhile, Shire is pressing forward with a company-record 21 drugs in clinical development, buidling what CEO Flemming Ornskov says is its strongest pipeline ever. Shire is moving on after AbbVie's ($ABBV) plot to buy the company for $55 billion fell apart last year, giving the Irish drugmaker a new lease on freedom and a $1.6 billion breakup fee for its trouble.

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