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獲得FDA對VX-880治療1型糖尿病的快速通道稱號>VRTX
By Colin Kellaher
科林·凱萊赫(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製藥公司(Vertex PharmPharmticals Inc.)週三表示，美國食品和藥物管理局(FDA)批准VX-880快速通道，用於患有嚴重低血糖和低血糖意識受損的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.
這家波士頓製藥商表示，它已經啟動了VX-880的1/2期臨牀試驗。VX-880是一種研究同種異體人類幹細胞衍生的胰島細胞療法，該公司認為，這種療法有可能通過恢復胰島細胞功能(包括胰島素產生)來恢復人體調節血糖水平的能力。
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的快速通道計劃旨在促進開發和加快審查嚴重或潛在危及生命的疾病的治療方法，這些疾病有很高的醫療需求未得到滿足。
Vertex said VX-880 is the first and only pancreatic islet replacement therapy known to receive the designation.
Vertex説，VX-880是已知的第一種也是唯一一種獲得指定的胰島替代療法。
Write to Colin Kellaher at colin.kellaher@wsj.com
寫信給Colin Kellaher，電子郵件：colin.kellaher@wsj.com
(END) Dow Jones Newswires
(完)道瓊通訊社
March 10, 2021 08:22 ET (13:22 GMT)
2021年3月10日東部時間08：22(格林尼治標準時間13：22)
Copyright (c) 2021 Dow Jones & Company, Inc.
版權所有(C)2021年道瓊斯公司
譯文內容由第三人軟體翻譯。
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