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FDA认为Chelsea的Northera存在技术缺陷

  1. Chelsea
  2. Northera

来源:生物谷 2013-07-31 11:49

2013年7月30日讯 /生物谷BIOON/ --FDA本月早些时候宣布Chelsea公司研制的治疗帕金森症等中枢神经系统的药物Northera (droxidopa) 在研发当中存在技术缺陷。早在2012年3月,FDA就曾否决过该药物的申请,并要求Chelsea补充更详尽的研究数据。今年早些时候公司再次将药物提交FDA,FDA在仔细研究后通知Chelsea公司该结论。

2013年7月30日讯 /生物谷BIOON/ --FDA本月早些时候宣布Chelsea公司研制的治疗帕金森症等中枢神经系统的药物Northera (droxidopa) 在研发当中存在技术缺陷。早在2012年3月,FDA就曾否决过该药物的申请,并要求Chelsea补充更详尽的研究数据。今年早些时候公司再次将药物提交FDA,FDA在仔细研究后通知Chelsea公司该结论。消息一经披露,公司股价大幅下跌。而公司负责人称,公司将很快修改该技术缺陷,并最早于八月份再次提交FDA申请。(生物谷Bioon.com)

详细英文报道:

In another setback for Chelsea Therapeutics ($CHTP), drug regulators have identified certain technical deficiencies for the biotech's lead investigational therapeutic Northera (droxidopa) in a review of the company's resubmitted New Drug Application.

Northera is designed to prevent symptomatic neurogenic orthostatic hypotension--dizziness and fainting among patients with disorders of the nervous system, such as Parkinson's disease. The FDA denied approval for the therapy in March 2012, concluding that Chelsea would need to file positive data from additional studies. Regulators also raised safety concerns about the drug's links to a neurological condition and are considering a black box warning. The Charlotte, NC-based biotech resubmitted its application to the FDA earlier this month.

In the latest chapter in Chelsea's pipeline troubles, the FDA has notified Chelsea that the deficiencies are related to the formatting of certain electronic datasets and statistical programs describing the methods used to generate tables and listings that the company submitted. A company press release says the deficiencies the FDA noted are unrelated to study conduct, interpretability of study results or validity of study conclusions.

"The company believes that the matter can be resolved quickly, and expects to submit the necessary response in August," Chelsea said in a statement on Monday.

Earlier this month, Chelsea received written confirmation from the FDA that the resubmission was deemed to be a complete response to the FDA's March 2012 letter, and the company was assigned a new review date of January 3, 2014. That timeline will now be pushed back until the FDA receives a response with the agency's requested changes.

Shares of Chelsea were down 7.82% at $2.83 as of 9:15 a.m. Monday.

 

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