Gilead Sciences Statement on Request to Rescind Remdesivir orphan Drug Designation Gilead has submitted a request to the U.S. Food and Drug Administration to rescind the orphan drug designation it was granted for the investigational antiviral remdesivir for the treatment of COVID-19 and is waiving all benefits that accompany the designation. Gilead is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir, without the orphan drug designation. Recent engagement with regulatory agencies has demonstrated that submissions and review relating to remdesivir for the treatment of COVID-19 are being expedited. 
In early March, Gilead sought and was subsequently granted an orphan drug designation for the remdesivir as a potential treatment for COVID-19. orphan drug designation is granted by the FDA in situations where the disease affects fewer than 200,000 patients in the United States. 
Among the benefits of orphan drug designation, this status results in a waiver of the requirement to provide a pediatric study plan prior to the submission of a New Drug Application – a process that can to take up to 210 days to review. 
Gilead recognizes the urgent public health needs posed by the COVID-19 pandemic.  The company is working to advance the development of remdesivir as quickly as possible, and will provide updates as they become available.

日前，吉利德科学公司的在研抗病毒疗法瑞德西韦（remdesivir）获得美国FDA授予的孤儿药资格（orphan drug designation），适应症为新冠病毒病（COVID-19）。这一消息引起了不少争议，有些业界人士担心孤儿药资格可能会影响瑞德西韦的可及性。今日，吉利德科学（Gilead Sciences）公司发布声明，宣布已经向美国FDA提出申请，要求 FDA收回授予瑞德西韦的孤儿药资格，并且放弃与孤儿药资格相关的所有优惠权益。

吉利德科学表示，有信心即使在没有孤儿药资格的情况下，仍能保持瑞德西韦监管审评过程的加速完成。近日该公司与监管机构的交流表明，与瑞德西韦治疗COVID-19相关的申请和审评都将被加快。

在4月初，较有利德地理学向FDA寻求合作有弃儿药请求条件，规划设计建设瑞德西韦当做诊疗COVID-19的意向療法。弃儿药请求条件是FDA表杨规划设计建设诊疗令人震惊病的控制措施之首，为国药新公司规划设计建设在研療法展示好几种优惠待遇减免策略。但其中一笔优惠待遇减免是能撤职在抗癌新药请求前提交小儿科设计预计（pediatric study plan）。这工作的审评周期概率历时210天。

吉利德科学公司在声明中表示：“ 吉利德认识到COVID-19大流行病带来的紧急公共卫生需求。公司正在以尽可能快的速度推进瑞德西韦的开发。”

瑞德西韦是遭遇范围广了解的抗虫毒在研针灸，它当前在6项临床药学上疲劳应力测试中确认考察，治療各个类形的COVID-19患有。在其中，在我国的开始的各项临床药学上疲劳应力测试已成定局在4日份可以获得报告单。

3月23日，FDA官网数据库显示，FDA授予吉利德科学（Gilead Sciences）公司开发的在研抗病毒疗法瑞德西韦（remdesivir）孤儿药资格（Orphan Drug Designation），其适应症为冠状病毒疾病2019（COVID-19）。

 

  FDA的遗孤药从业申批资格认证该项目从而提高网站制疗难见慢性病或现状的性制剂或微生物材质的设计规划技术。难见慢性病的基本概念是在美式疾患用户大于30万人。有遗孤药从业申批资格的在研方法行有一编提高网站性制剂设计规划技术的实惠，至少首要的那条是如何该方法的遗孤药适用症有报批，该性制剂行在某一适用症角度拥有10年专业市场霸占期（exclusivity）。代表着着如何FDA报批瑞德西韦在制疗COVID-19，10年内其他医疗机械工司设计规划技术的仿制药是不能在美式香港上市。除此范围内，在性制剂设计规划技术时候中，研发部门工司还行有与合格证临床检验測試一些的稅务抵免，相应申批抗癌新药申批时指定区域资金的免征等其他实惠。   非常较有利德数学企业规划设计的瑞德西韦近日成2025世俱杯官网 了解的无线热点抗癫痫药物。它不是款抗病力毒療法，其影响长效机制为调控RNA依赖于性RNA缔合酶的活性氧，然后调控RNA病毒样本的增值。到目前为止，非常较有利德企业未能进度6项医学冲击试验报告，验证瑞德西韦方法各种类别的COVID-19的人的的作用。这其中，在国内完成的二项医学冲击试验报告现已在4月荣获的结果。   因为充分满足可能发生的素市场需求，该平台以经发展瑞德西韦的产出工作能力，然后将产出几种瑞德西韦的配形式（透明液体和冻干）。昨夜，该平台表达出来，现在将供应人个可怜施用（compassionate use）紧急情况节点调整到发展施用項目（expanded access programs），这样形式将促使危重症自身拥有瑞德西韦的时候，并并能获取因此体验自身的统计数据。这样的項目现在与中国亚洲各国风险防控平台协同快速的开发设计。

3月18日，众所期待的洛匹那韦-利托那韦治疗新冠临床试验结果，在《新英格兰医学杂志》上发布，结果让人失望，在重症患者中，与常规治疗相比，研究未能观察到洛匹那韦-利托那韦治疗的有效性。

11月初，此次评价洛匹那韦-利托那韦进行治疗新冠的医学试验检测，在南昌黄金潭青岛博士整形医院医院进行。

检测共纳为199名新冠新冠木马诊断糖尿病患者，自由进行普通控制组，和普通控制加匹那韦-利托那韦控制。临床实践可以改善和新冠木马清理掉时候是两只关键点指標，最终结果呈现：

临床症状改善：两组患者出现临床状况改善中位时间相同，均为16天。洛匹那韦-利托那韦组与常规治疗组患者的风险比为1.31（95% 置信度，0.95-1.80），未能表现出显著差异。

病毒清除情况：与常规治疗组相比，洛匹那韦-利托那韦没有降低病毒RNA载量，也无法缩短检出病毒RNA的时间。试验结束时（第28天），洛匹那韦-利托那韦组有40.7%的患者仍可检出新冠病毒RNA，和常规治疗组无差异。

前者，在安全性能高性领域，洛匹那韦-利托那韦组提高导致了4起直消化道嚴重不健康现象行为（收录难受、反胃和腹泻拉稀），而传统缓解组未发生直消化道嚴重不健康现象行为。

综合结果是：和常规治疗相比，洛匹那韦-利托那韦治疗，在改善临床症状和清除病毒方面并无优势，还有可能增加不良反应。

相对于洛匹那韦-利托那韦

洛匹那韦-利托那韦，物品名克力芝，2000年获FDA申批挂牌上市，主要用于治疗方法艾滋病毒。

在此之前的SARS情况和MERS情况爆发性后，洛匹那韦-利托那韦都是有升值空间的的治疗性药物，但在临床研究试验检测中，都没导致确凿的能够离婚证据。

针对COVID-19，洛匹那韦-利托那韦还是无效。在，只可看好瑞德西韦临床数据了。

关干四期请点：

左右是三期诊疗冲击试验规划：

Arm	Intervention/treatment
Experimental: Remdesivir (RDV), 5 Days Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, and 5.	Drug: Remdesivir Administered as an intravenous infusion Other Name: GS-5734™                      Drug: Standard of Care Standard of care therapy per local written policies or guidelines
Experimental: Remdesivir, 10 Days Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10.	Drug: Remdesivir Administered as an intravenous infusion Other Name: GS-5734™                      Drug: Standard of Care Standard of care therapy per local written policies or guidelines
Active Comparator: Continued SOC Therapy Participants will receive continued standard of care therapy.	Drug: Standard of Care Standard of care therapy per local written policies or guidelines

Outcome Measures

 

Primary Outcome Measures :

1. Proportion of Participants Discharged by Day 14 [ Time Frame: First dose date or randomization date up to 14 days ]
   

             ;  

Secondary Outcome Measures :

1. Proportion of Participants With Treatment Emergent Adverse Events Leading to Study Drug Discontinuation [ Time Frame: First dose date up to 10 days ]

Eligibility Criteria

Ages Eligible for Study:	18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

           

Criteria

   

Key Inclusion Criteria:

• Willing and able to provide written informed consent prior to performing study procedures
• Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization
• Currently hospitalized with fever defined as temperature ≥ 36.6 °C armpit, ≥ 37.2 °C oral, or ≥ 37.8 °C rectal
• Peripheral capillary oxygen saturation (SpO2) > 94% on room air at screening
• Radiographic evidence of pulmonary infiltrates

Key Exclusion Criteria:

• Participation in any other clinical trial of an experimental treatment for COVID-19
• Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study drug dosing
• Requiring mechanical ventilation at screening
• Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)
• Creatinine clearance < 50 mL/min

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Brief Summary:

 

The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens compared to standard of care (SOC), with respect to the time to discharge in participants with moderate coronavirus disease (COVID-19).

     

Condition or disease	Intervention/treatment	Phase
COVID-19	Drug: Remdesivir               Drug: Standard of Care	Phase 3

Study Design 

Study Type :	Interventional                 (Clinical Trial)
EstimatedEnrollment :	600 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate COVID-19 Compared to Standard of Care Treatment
Estimated Study Start Date :	March 2020
Estimated Primary Completion Date :	May 2020
Estimated Study Completion Date :	May 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Remdesivir (RDV), 5 Days Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, and 5.	Drug: Remdesivir Administered as an intravenous infusion Other Name: GS-5734™                      Drug: Standard of Care Standard of care therapy per local written policies or guidelines
Experimental: Remdesivir, 10 Days Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10.	Drug: Remdesivir Administered as an intravenous infusion Other Name: GS-5734™                      Drug: Standard of Care Standard of care therapy per local written policies or guidelines
Active Comparator: Continued SOC Therapy Participants will receive continued standard of care therapy.	Drug: Standard of Care Standard of care therapy per local written policies or guidelines

Outcome Measures

Primary Outcome Measures :

1. Proportion of Participants Discharged by Day 14 [ Time Frame: First dose date or randomization date up to 14 days ]
   

   
               

Secondary Outcome Measures :

1. Proportion of Participants With Treatment Emergent Adverse Events Leading to Study Drug Discontinuation [ Time Frame: First dose date up to 10 days ]

Eligibility Criteria

Ages Eligible for Study:	18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

           

Criteria

   

Key Inclusion Criteria:

• Willing and able to provide written informed consent prior to performing study procedures
• Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization
• Currently hospitalized with fever defined as temperature ≥ 36.6 °C armpit, ≥ 37.2 °C oral, or ≥ 37.8 °C rectal
• Peripheral capillary oxygen saturation (SpO2) > 94% on room air at screening
• Radiographic evidence of pulmonary infiltrates

Key Exclusion Criteria:

• Participation in any other clinical trial of an experimental treatment for COVID-19
• Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study drug dosing
• Requiring mechanical ventilation at screening
• Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)
• Creatinine clearance < 50 mL/min

Note: Other protocol defined Inclusion/Exclusion criteria may apply.