GlaxoSmithKline Gets FDA Approval for Blood-Disorder Drug Nucala
GlaxoSmithKline Gets FDA Approval for Blood-Disorder Drug Nucala
DJ GlaxoSmithKline Gets FDA Approval for Blood-Disorder Drug Nucala
By Kimberly Chin
GlaxoSmithKline PLC has received the U.S. Food and Drug Administration's approval for the drug Nucala, which treats adult and pediatric patients with hypereosinophilic syndrome, a type of blood disorder.
Nucala will become the first and only targeted biologic treatment to win approval for patients with eosinophil-driven disease in the U.S., the company said. Eosinophils are a type of white blood cell.
The FDA's approval follows a review of data from the company's Phase 3 study, GlaxoSmithKline said. The results showed 50% fewer patients experienced worsening symptoms or required an escalation in treatment compared with the use of a placebo, the company said.
The results were recently published in the Journal of Allergy and Clinical Immunology.
Nucala is currently used as treatment for several other eosinophil-driven diseases.
Write to Kimberly Chin at kimberly.chin@wsj.com
(END) Dow Jones Newswires
September 25, 2020 16:48 ET (20:48 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
DJ GlaxoSmithKline Gets FDA Approval for Blood-Disorder Drug Nucala
DJ葛蘭素史克(GlaxoSmithKline)獲得FDA批准用於治療血液疾病的藥物努卡拉(Nucala)
By Kimberly Chin
作者：金伯利·陳(Kimberly Chin)
GlaxoSmithKline PLC has received the U.S. Food and Drug Administration's approval for the drug Nucala, which treats adult and pediatric patients with hypereosinophilic syndrome, a type of blood disorder.
葛蘭素史克已經獲得了美國食品和藥物管理局(FDA)對紐卡拉(Nucala)藥物的批准，該藥物用於治療患有高嗜酸性粒細胞綜合徵(一種血液疾病)的成人和兒童患者。
Nucala will become the first and only targeted biologic treatment to win approval for patients with eosinophil-driven disease in the U.S., the company said. Eosinophils are a type of white blood cell.
該公司表示，Nucala將成為美國第一個也是唯一一個獲得批准的針對嗜酸性粒細胞驅動疾病患者的有針對性的生物治療方法。嗜酸性粒細胞是白細胞的一種。
The FDA's approval follows a review of data from the company's Phase 3 study, GlaxoSmithKline said. The results showed 50% fewer patients experienced worsening symptoms or required an escalation in treatment compared with the use of a placebo, the company said.
葛蘭素史克表示，FDA的批准是在對該公司第三階段研究的數據進行審查後獲得的。該公司表示，結果顯示，與使用安慰劑相比，出現症狀惡化或需要升級治療的患者減少了50%。
The results were recently published in the Journal of Allergy and Clinical Immunology.
這項研究結果最近發表在《過敏與臨牀免疫學》雜誌上。
Nucala is currently used as treatment for several other eosinophil-driven diseases.
努卡拉目前被用於治療其他幾種嗜酸性粒細胞驅動的疾病。
Write to Kimberly Chin at kimberly.chin@wsj.com
寫信給Kimberly Chin，電子郵件：kimberly.chin@wsj.com
(END) Dow Jones Newswires
(完)道瓊通訊社
September 25, 2020 16:48 ET (20:48 GMT)
2020年9月25日美國東部時間16：48(格林尼治標準時間20：48)
Copyright (c) 2020 Dow Jones & Company, Inc.
版權所有(C)2020道瓊斯公司。
譯文內容由第三人軟體翻譯。
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