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美国制药商礼来Eli Lilly制药因安全性问题而暂停抗体试验

2020-10-14 15:22

 

新华社华盛顿10月13日电美国礼来制药公司13日宣布,出于安全考虑,已暂停一种治疗COVID-19的联合抗体的试验。


该公司表示,试验数据安全监测委员会(DSMB)——一个监督临床试验的独立医学专家小组——建议暂停。


礼来公司发言人在一份声明中说:“这项试验是由美国国家卫生研究院下属的美国国家过敏和传染病研究所(NIAID)赞助的,旨在评估礼来公司的试验性中和抗体是否可以用于治疗住院患者的COVID-19。”


“礼来公司支持独立的DSMB的决定,谨慎地确保参与这项研究的患者的安全,”声明说。


无论是礼来制药公司还是赞助这项试验的美国国家药品和药物管理局,都没有描述导致暂停这项研究的安全问题。


这项研究是在美国进行的测试在不同环境下使用抗体治疗的几个研究之一。


礼来公司本月早些时候宣布,新的数据显示,联合使用礼来公司的两种SARS-CoV-2中和抗体可以减少病毒载量、症状、与covid相关的住院和急诊次数。


随机、双盲、安慰剂对照的2期研究评估了LY-CoV555和LY-CoV016,它们结合了SARS-CoV-2 spike蛋白的互补区域,用于门诊对症治疗COVID-19。


联合队列纳入了最近诊断为轻度至中度COVID-19的患者,他们被分配到每种抗体2800毫克或安慰剂。


该公司表示已经向美国食品和药物管理局提交了单一药物治疗的紧急使用授权(EUA)申请。


在礼来公司决定暂停试验之前,美国制药公司强生公司(Johnson & Johnson)周一晚间宣布,由于一名参与者患病,暂停了COVID-19疫苗的试验。

 

WASHINGTON, Oct. 13 (Xinhua) -- U.S. drugmaker Eli Lilly said Tuesday it has paused its trial of a combination antibody treatment for COVID-19 for safety reasons.

The company said the trial's Data Safety Monitoring Board (DSMB), an independent group of medical experts who monitor clinical trials, recommended the pause.

"The trial, evaluating Lilly's investigational neutralizing antibody as a treatment for COVID-19 in hospitalized patients, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH)," a Lilly spokesperson said in a statement.

"Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study," said the statement.

Neither Eli Lilly nor the NIAID, which is sponsoring the trial, have described the safety issue that prompted the decision to pause the study.

The study is one of several being conducted in the United States to test the use of the antibody treatment in various settings.

Eli Lilly announced earlier this month that new data showed that combination therapy with two of Lilly's SARS-CoV-2 neutralizing antibodies reduced viral load, symptoms and COVID-related hospitalization and emergency room visits.

The randomized, double-blind, placebo-controlled Phase 2 study evaluated LY-CoV555 and LY-CoV016, which bind complementary regions of the SARS-CoV-2 spike protein, for the treatment of symptomatic COVID-19 in the outpatient setting.

The combination cohort enrolled recently diagnosed patients with mild-to-moderate COVID-19, who were assigned to 2,800 mg of each antibody or placebo.

The company said it has submitted request for emergency use authorization (EUA) for monotherapy to the U.S. Food and Drug Administration.

Eli Lilly's decision to pause trial followed the announcement of U.S. pharmaceutical company Johnson & Johnson, which announced late Monday it had paused its COVID-19 vaccine trial because one of its participants had become sick.

 

来自: xinhua