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Shire干眼病药物lifitegrast将提交FDA

  1. lifitegrast
  2. Shire
  3. 干眼病

来源:生物谷 2014-05-22 14:49

生物技术公司Shire公司最近宣布,公司将于明年的第一季度将公司开发的干眼病药物lifitegrast提交FDA审核,然而lifitegrast表现平平的临床三期研究数据为Shire公司规划的审批之路蒙上了一层阴影。

2014年5月22日讯 /生物谷BIOON/ --生物技术公司Shire公司最近宣布,公司将于明年的第一季度将公司开发的干眼病药物lifitegrast提交FDA审核,然而lifitegrast表现平平的临床三期研究数据为Shire公司规划的审批之路蒙上了一层阴影。在一项有718名患者参与的临床三期研究中,虽然lifitegrast达到了缓解干眼病症状的预期目标,但是却没能成功完成角膜染色方面的指标。因此这一项数据其实仍然拷问着该药物的有效性。

不过现在Shire公司仍然决定在申报同时,招募一批有1800患者参与的实验以向FDA证明这一药物的有效性和安全性。

Lifitegrast主要是通过阻断眼部的整合素来防止炎症发生并最终治疗干眼病的。Shire公司于去年在收购SARcode生物技术公司时获得了这一产品。公司希望以这一产品为突破口来建立起一个眼科疾病药物体系。(生物谷Bioon.com)

详细英文报道:

Shire ($SHPG) is gearing up to file an FDA application for lifitegrast, a dry eye treatment it picked up for $160 million, despite some mixed results in a late-stage trial.

The company plans to hand in its NDA in the first quarter of 2015, wrapping up chemistry and manufacturing work in the meantime. The treatment, which starred in Shire's buyout of SARcode Bioscience last year, is a keystone in the drugmaker's quest to build an ophthalmology franchise, but, thanks to a disappointing Phase III trial, those plans might be put on hold.

In a 718-patient study, lifitegrast met the coprimary endpoint of relieving dry eye symptoms compared to placebo but missed the mark on signs of corneal staining, a biomarker for the disease. That 50-50 split led some analysts to question the drug's approvability, figuring the FDA would require a second efficacy trial before green-lighting lifitegrast.

Now Shire is taking a cautious step forward, figuring its combined results on more than 1,800 patients adequately demonstrate lifitegrast's safety and efficacy. In parallel with its NDA preparation, though, Shire said it "will be assessing the need for gathering additional clinical data" on the drug, an acknowledgement that the missed endpoint may pose a threat to the treatment's regulatory future.

Shire is counting on lifitegrast to spell its entry point into the world of ophthalmology, and the company has recruited Bausch + Lomb veteran Robert Dempsey to head up a new business unit dedicated to the field. Behind the dry eye drug, Shire is in the midst of Phase II study with SHP607, designed to prevent a retinal ailment that afflicts premature infants, and the company has "every intention of complementing these compounds with additional pipeline products to address significant unmet patient need in ophthalmics," CEO Flemming Ornskov said in a statement.

The turn toward eye drugs is part of Ornskov's move to institute sweeping R&D reforms since taking the reins last year. The move is both an acknowledgement of the ophthalmology space's growth over the past few years and a return to form for the CEO, who ran Novartis' ($NVS) eye drug business before moving over to Bausch + Lomb.

Lifitegrast is a topical therapy that works by blocking the protein integrin, thereby reducing inflammation and relieving symptoms of dry eye disease, according to Shire.

 

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