Vertex Gets FDA Fast-Track Designation for VX-880 in Type 1 Diabetes >VRTX
Vertex Gets FDA Fast-Track Designation for VX-880 in Type 1 Diabetes >VRTX
DJ Vertex Gets FDA Fast-Track Designation for VX-880 in Type 1 Diabetes >VRTX
By Colin Kellaher
Vertex Pharmaceuticals Inc. Wednesday said the U.S. Food and Drug Administration granted fast-track designation to VX-880 for patients who have type 1 diabetes with severe hypoglycemia and impaired hypoglycemic awareness.
The Boston drug maker said it has launched a Phase 1/2 clinical trial of VX-880, an investigational allogeneic human stem cell-derived islet cell therapy that it believes has the potential to restore the body's ability to regulate glucose levels by restoring pancreatic islet cell function, including insulin production.
The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.
Vertex said VX-880 is the first and only pancreatic islet replacement therapy known to receive the designation.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
March 10, 2021 08:22 ET (13:22 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
DJ Vertex Gets FDA Fast-Track Designation for VX-880 in Type 1 Diabetes >VRTX
DJ Vertex获得FDA对VX-880治疗1型糖尿病的快速通道称号>VRTX
By Colin Kellaher
科林·凯莱赫(Colin Kellaher)著
Vertex Pharmaceuticals Inc. Wednesday said the U.S. Food and Drug Administration granted fast-track designation to VX-880 for patients who have type 1 diabetes with severe hypoglycemia and impaired hypoglycemic awareness.
Vertex制药公司(Vertex PharmPharmticals Inc.)周三表示，美国食品和药物管理局(FDA)批准VX-880快速通道，用于患有严重低血糖和低血糖意识受损的1型糖尿病患者。
The Boston drug maker said it has launched a Phase 1/2 clinical trial of VX-880, an investigational allogeneic human stem cell-derived islet cell therapy that it believes has the potential to restore the body's ability to regulate glucose levels by restoring pancreatic islet cell function, including insulin production.
这家波士顿制药商表示，它已经启动了VX-880的1/2期临床试验。VX-880是一种研究同种异体人类干细胞衍生的胰岛细胞疗法，该公司认为，这种疗法有可能通过恢复胰岛细胞功能(包括胰岛素产生)来恢复人体调节血糖水平的能力。
The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.
FDA的快速通道计划旨在促进开发和加快审查严重或潜在危及生命的疾病的治疗方法，这些疾病有很高的医疗需求未得到满足。
Vertex said VX-880 is the first and only pancreatic islet replacement therapy known to receive the designation.
Vertex说，VX-880是已知的第一种也是唯一一种获得指定的胰岛替代疗法。
Write to Colin Kellaher at colin.kellaher@wsj.com
写信给Colin Kellaher，电子邮件：colin.kellaher@wsj.com
(END) Dow Jones Newswires
(完)道琼通讯社
March 10, 2021 08:22 ET (13:22 GMT)
2021年3月10日东部时间08：22(格林尼治标准时间13：22)
Copyright (c) 2021 Dow Jones & Company, Inc.
版权所有(C)2021年道琼斯公司
译文内容由第三方软件翻译。
风险及免责提示
- 分享到weixin
- 分享到qq
- 分享到facebook
- 分享到twitter
- 分享到微博
- 粘贴板
使用浏览器的分享功能，分享给你的好友吧