FDA授予卫材淋巴瘤药物E7777孤儿药地位

安，释然

       2013年8月10日讯 /生物谷BIOON/ --卫材（Eisai）8月9日宣布，FDA已授予实验性化合物E7777用于治疗皮肤T细胞淋巴瘤（CTCL）的孤儿药地位（orphan drug status）。E7777被设计成具有一种改善的纯度属性和制造工艺，目前正处于一个关键临床试验，相关数据将用于支持相关监管申请文件的提交。
       在美国，如果所开发的药物是用于少于20万患者群体的治疗，孤儿药法案（Orphan Drug Act，ODA）允许FDA授予该药孤儿药地位。FDA的决定意味着卫材将得到税收优惠及开发E7777的其他一些利益。
       皮肤T细胞淋巴瘤（cutaneous T-cell lymphoma, CTCL）属于非霍奇金淋巴瘤（Non-Hodgkin’s lymphoma, NHL）中的一种，是原发于皮肤的、由T淋巴细胞克隆性增生造成的疾病，由一组临床表现、组织学特征、及病程预后各不相同的疾病组成。皮肤T细胞淋巴瘤占所有原发性皮肤淋巴瘤的75%-80%。（生物谷Bioon.com）
       英文原文：Eisai's investigational compound for cutaneous T-Cell lymphoma receives US FDA orphan drug status
Saturday, August 10, 2013, 09:00 Hrs  [IST]  
The US Food and Drug Administration (FDA) has granted orphan drug designation to Eisai Inc.'s investigational compound (E7777) for cutaneous t-cell lymphoma (CTCL). E7777 is designed to have an improved purity profile and manufacturing process. It is currently in a pivotal trial intended to support its submission for approval.
The Orphan Drug Act (ODA) allows FDA to grant orphan status to a drug which has the potential for the treatment, diagnosis, or prevention of a rare disease/disorder that affects fewer than 200,000 people in the United States.
CTCL is a rare type of cancer that begins in the white blood cells and attacks the skin. It is one of several types of lymphoma collectively called non-Hodgkin lymphoma.
Eisai Inc., gives first thought to patients and their families, and helping to increase the benefits health care provides. The main goal is human health care.
Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system.