打开APP

FDA授予GW公司药物Epidiolex快速通道地位

  1. Epidiolex
  2. GW制药
  3. 大麻素

来源:生物谷 2014-06-09 09:12

FDA授予GW制药公司实验性药物Epidiolex快速通道地位,此前FDA已授予该要孤儿药地位。Epidiolex(大麻二酚)是一种源于大麻的药物。

2014年6月7日讯 /生物谷BIOON/ --英国GW制药(GW pharmaceuticals)6月6日宣布,FDA已授予实验性大麻二酚(CBD)Epidiolex治疗Dravet综合征的快速通道地位。Dravet综合征是一种罕见和灾难性的难治性儿童癫痫。

除Dravet综合征,GW计划开展一项临床项目,调查Epidiolex用于Lennox-Gastaut综合征(LGS)的治疗。今年早些时候,FDA已授予Epidiolex治疗LGS的孤儿药地位。GW计划于2014年中期与FDA进行会谈,并计划于2015年开展2项III期LGS研究。

关于Dravet综合征:

Dravet综合征(Dravet syndrome,DS)又称婴儿严重肌阵挛性癫痫,是一种少见的主要由遗传因素引起的进行性癫痫性脑病,发病率约为(0.5~4)万,占3岁以内婴幼儿童癫痫的7%。Dravet综合征(DS)具有发病年龄早,发作类型多样,发作频率高,智能损害严重,药物治疗效果差等特点。该病预后较差,几乎所有患儿都有认知损伤。

关于GW制药公司:

GW公司成立于1998年,是一家生物制药公司,致力于发现、开发、商业化来自其专有的大麻产品平台的新颖疗法,用于广泛疾病的治疗。GW商业化推出了世界首个植物源性大麻素处方药Sativex,该药已获25个国家批准用于治疗多发性硬化症导致的痉挛。目前,Sativex正处于III期临床,作为一种潜在的疗法用于晚期癌症患者疼痛的治疗。GW公司的研发管线中拥有广泛的大麻素候选药物,包括孤儿药Epidiolex及其他化合物。

英文原文:GW Pharmaceuticals Announces Epidiolex® Receives Fast Track Designation from FDA for the Treatment of Dravet Syndrome

London, UK; 6 June 2014: GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: GWP, “GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation to GW’s investigational cannabidiol (CBD) product, Epidiolex®, in the treatment of Dravet syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy.

FDA's Fast Track program facilitates the development and review of drugs intended to treat serious conditions and fill an unmet medical need. A drug development program with Fast Track designation is afforded greater access to the FDA for the purpose of expediting the drug's development, review and potential approval to get important new drugs to the patient earlier.

“GW is focused on advancing the Epidiolex development program as rapidly as possible with the aim of addressing the significant unmet need in children suffering from Dravet syndrome. The granting of Fast Track designation, in addition to Epidiolex having already received orphan drug designation from the FDA, represents significant additional support toward this objective,” stated Justin Gover, GW’s Chief Executive Officer. “With GW having already opened an Investigational New Drug (IND) for Epidiolex, we are on track to commence a Phase 2/3 clinical trial in Dravet syndrome in the second half of this year.”
In addition to Dravet syndrome, GW plans to conduct a clinical development program for Epidiolex in the treatment of Lennox-Gastaut syndrome (LGS). Following receipt earlier in 2014 of orphan drug designation by the FDA in LGS, GW expects to hold a pre-IND meeting with the FDA for Epidiolex in the treatment of LGS in mid-2014, and expects to conduct two Phase 3 trials in LGS during 2015.
 
About Dravet syndrome
Dravet syndrome, also known as Severe Myoclonic Epilepsy of Infancy (SMEI), is a rare and catastrophic form of epilepsy for which there is currently no cure. Seizures begin in the first year of life in an otherwise typically developing infant. Initial seizures are most often prolonged events (status epilepticus) and, in the second year of life, other seizure types emerge. All seizure types are remarkably resistant to medical therapy and the prognosis for Dravet syndrome is poor. Individuals with Dravet syndrome face a higher incidence of SUDEP (sudden unexplained death in epilepsy) and have associated co-morbid conditions, which also need to be properly managed. Children with Dravet syndrome do not outgrow this condition and it affects every aspect of their daily lives.
 
About GW Pharmaceuticals plc
Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis in 25 countries. Sativex is also in Phase 3 clinical development as a potential treatment of pain in people with advanced cancer. This Phase 3 program is intended to support the submission of a New Drug Application for Sativex in cancer pain with the U.S. Food and Drug Administration and in other markets around the world. GW has a deep pipeline of additional cannabinoid product candidates, including Epidiolex which has received Orphan Drug Designation from the FDA for the treatment of Dravet and Lennox-Gastaut syndromes, severe, drug-resistant epilepsy syndromes. GW’s product pipeline also includes compounds in Phase 1 and 2 clinical development for glioma, ulcerative colitis, type‑2 diabetes, and schizophrenia.

版权声明 本网站所有注明“来源:生物谷”或“来源:bioon”的文字、图片和音视频资料,版权均属于生物谷网站所有。非经授权,任何媒体、网站或个人不得转载,否则将追究法律责任。取得书面授权转载时,须注明“来源:生物谷”。其它来源的文章系转载文章,本网所有转载文章系出于传递更多信息之目的,转载内容不代表本站立场。不希望被转载的媒体或个人可与我们联系,我们将立即进行删除处理。

87%用户都在用生物谷APP 随时阅读、评论、分享交流 请扫描二维码下载->