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FDA承诺加快对Boehringer肺部疾病药物审批

来源:生物谷 2014-07-04 08:53

2014年7月4日讯 /生物谷BIOON/ --FDA最近表示将对勃林格殷格翰公司开发的用于治疗肺部疾病特发性肺纤维化(idiopathic pulmonary fibrosis (IPF))药物nintedanib进行优先审核。这一决定也将加快其上市的审批流程并在与InterMune公司相似药物竞争中迎头赶上。勃林格殷格翰公司进行了两项超过1000名患者参与的临床上拿起研究,分别发现nintedanib将患者肺功能年平均丧失率降低了48%和55%,而对照组仅为5%。在美国目前还没有一种治疗IPF的特效药物,据了解,美国每年有40000人死于该病。

而勃林格殷格翰公司的竞争对手InterMune公司开发的类似产品Pirfenidone则已经在今年五月份提交FDA审核并预计在六个月内获得批准。(生物谷Bioon.com)

详细英文报道:

The FDA is guaranteeing a priority review for Boehringer Ingelheim's much-watched treatment for a rare lung disease, likely speeding up the drug's path to market as the German pharma races with biotech InterMune ($ITMN).

Boehringer's treatment, dubbed nintedanib, is a therapy for idiopathic pulmonary fibrosis (IPF), an often fatal disease that scars the lungs and stands in the way of oxygen absorption. In two Phase III studies on more than 1,000 patients, the drug reduced patients' annual rate of lung-function decline by 48% and 55%, compared to just 5% with placebo arm.

In the U.S., there are no approved treatments for IPF, which kills about 40,000 people a year, according to the Coalition for Pulmonary Fibrosis. The FDA's priority review designation for nintedanib will give Boehringer wider access to regulators and a faster path to a final decision, under agency rules, a regulatory victory that should come in handy as the company strives to hit the U.S. market before an encroaching rival.

Pirfenidone, InterMune's competing IPF drug, endured an FDA rejection in 2010, but, thanks to promising new Phase III studies, the biotech has worked its way back into the good graces of investors. InterMune resubmitted the treatment in May and expects to win approval within 6 months, launching pirfenidone in the first quarter of 2015 if all goes according to plan.

Boehringer isn't disclosing its planned timeline for nintedanib, but even if InterMune wins the stateside race, the company has to like its commercial chances. Pirfenidone is already on the market in Europe, but, despite two years of momentum, the drug brought in just $70.2 million last year. The European Medicines Agency last month agreed to an accelerated review of nintedanib, and Boehringer, with its commercial heft, should be able to compete if and when it launches nintedanib on the continent.

Analysts have said the U.S. market for IPF treatments could peak at north of $2 billion, but just which company will claim the largest share of it remains up for debate. InterMune's shares shot up in March after Boehringer revealed that nintedanib missed a secondary endpoint in one of its Phase III trials, but a May editorial in The New England Journal of Medicine heralded the drug's efficacy and potential as a new hope for IPF patients.

 

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