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梯瓦帕金森药物Azilect新适应症获FDA批准

  1. Azilect
  2. 帕金森氏症
  3. 梯瓦
  4. 雷沙吉兰

来源:生物谷 2014-06-10 08:49

梯瓦帕金森氏症药物Azilect补充新药申请(sNDA)获FDA批准,目前,该药适应症已从单药疗法及左旋多巴(LD)辅助药物,扩大为多巴胺激动剂(DAs)的辅助药物。

2014年6月9日讯 /生物谷BIOON/ --梯瓦(Teva)6月9日宣布,FDA已批准扩大Azilect(rasagiline,雷沙吉兰片)的适应症,从单药疗法及左旋多巴(LD)辅助药物,扩大为多巴胺激动剂(DAs)的辅助药物。新适应症表明,Zzilect可单独用药或与其他帕金森氏症(PD)药物组合用药。此次批准,也加强了Azilect对横跨所有阶段PD群体治疗益处方面不断增长的临床证据。

Azilect扩展标签的批准,是基于梯瓦提交的一份补充新药申请(sNDA),该sNDA由ANDANTE研究的数据支持。ANADANTE研究在接受多巴胺激动剂(DAs)单药疗法的帕金森氏症患者中开展,数据表明,与安慰剂相比,Azilect显著改善了帕金森病评定量表总得分(UPDRS),为患者提供了临床治疗益处,同时表现出良好的耐受性。(生物谷Bioon.com)

英文原文:FDA Approves Expanded Label for AZILECT? for Treatment Across All Stages of Parkinson’s Disease

JERUSALEM--(BUSINESS WIRE)--Jun. 9, 2014-- Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced the U.S. Food and Drug Administration (FDA) has expanded the indication for AZILECT? (rasagiline tablets) from monotherapy and adjunct to levodopa (LD) to now include adjunct to dopamine agonists (DAs). The new indication reflects that AZILECT? can be used alone or in combination with other Parkinson’s disease (PD) medications. The approval reinforces the growing clinical evidence demonstrating the benefit of AZILECT? across all stages of PD.

“The FDA approval of the expanded label for AZILECT? will be a welcome addition in the treatment of PD,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva Pharmaceutical Industries Ltd. “Teva continues its commitment to those living with PD and to research in areas of neurodegenerative diseases to develop solutions for patients with unmet needs.”

The FDA approval of the expanded label is based on a supplemental new drug application (sNDA) submitted by Teva, supported by data from the ANDANTE study (Add oN to Dopamine AgoNists in the TrEatment of Parkinson’s disease).The study demonstrated AZILECT? provides a clinical benefit by significantly improving total Unified Parkinson’s Disease Rating Scale (UPDRS) scores compared to placebo in patients on DA monotherapy, while demonstrating tolerability.

“AZILECT? has been well studied and has been shown to be safe and effective as monotherapy in early PD and as an adjunct to LD in moderate-to-advanced PD. The ANDANTE study provides evidence that AZILECT? is also effective as an adjunct to dopamine agonist therapy,” said Robert A. Hauser, M.D., MBA, Professor of Neurology, Molecular Pharmacology, and Physiology at the University of South Florida. “The expanded AZILECT? indication supports the concept of adding AZILECT? to DA monotherapy to improve symptoms while offering another treatment option prior to either increasing the dose of DA monotherapy or initiating LD.”

ABOUT AZILECT?

INDICATION

AZILECT? (rasagiline tablets) is indicated for the treatment of Parkinson’s disease (PD).

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