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10月初，较有利德数学向FDA合作英语换取弃婴药基础，激发瑞德西韦看做诊治COVID-19的潜在的冶疗。弃婴药基础是FDA支持激发诊治珍稀病的处理最为，为生物医药平台激发在研冶疗具备种划算方案。表中那项划算是也可以免掉在仿制药注册前送审呼吸内科探析策划（pediatric study plan）。上述过程中 的审评时段可能性过去了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。”

瑞德西韦是面临具有广泛性关心的抵抗毒在研方式，它现阶段在6项临床实验查验冲击试验台中接受了查验，缓解各种不同款式的COVID-19病员。中仅，在国内 完成的几项临床实验查验冲击试验台已成定局在4四月刷出后果。

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的弃婴药条件鉴定内容契机使得改善稀少皮肤的疾病或系统的中成药或生物学肉食品的联合開發。稀少皮肤的疾病的理解是在意大利患者人次高于10万人。收获弃婴药条件的在研物理中医疗法都可以收获一系例使得中成药联合開發的优费免征，但其中核心的一点是比如该物理中医疗法的弃婴药应用症收获签发，该中成药都可以在这种应用症各方面给予六年的市场独揽期（exclusivity）。预兆着比如FDA签发瑞德西韦应用在改善COVID-19，六年内别生物制药企业联合開發的仿制药不可能在意大利主板上市。除此之外，在中成药联合開發的时候中，科研开发企业还都可以收获与完成临床护理测评各种相关的税务上的抵免，或者提交审请仿制药审请时相关保险费用的免征等别优费免征。   上汽名爵德生物学工厂開發的瑞德西韦近日来已成为必一运动 关心的热点事件药品。它一款抗病性毒开展方案，其效果制度为调控RNA依懒性RNA配位聚合酶的亲水性，故而调控RNA电脑病毒的增值能力。现，上汽名爵德工厂正处于进展情况6项临床实践实践实验室检测，检检瑞德西韦开展有差异业务类型的COVID-19病患者的功效。各举，在国内 去的几项临床实践实践实验室检测有希望在4月得到的结果。   要达到应该展现的十年后的中国需求分析，该子集团己经增大瑞德西韦的产出效率，如果将产出每种瑞德西韦的成分（介质和冻干）。往日，该子集团代表，到现下为止也在将具备必一运动 可怜用（compassionate use）紧急情况渠道缓冲间到扩充用好工程项目（expanded access programs），一些方式方法将提高危重提高有瑞德西韦的几率，并要能处理其它体验提高的的数据。这么多好工程项目到现下为止也在与全国世界国家政府监管学校联动快速的建设。

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。

4月初，重在考核洛匹那韦-利托那韦进行治疗新冠的临床实验实验，在广州金银珠宝潭医院医生落实。

试验装置共推行199名新冠新冠类病毒确珍客户，随即接收常規化缓解组，和常規化缓解加匹那韦-利托那韦缓解。临床治疗缓解和新冠类病毒解决状态是的两个关键性质量指标，最终屏幕上显示：

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。

另外，在很安全可靠性工作方面，洛匹那韦-利托那韦组客户出现了了4起消化道道较为为严重的异常情况的必一运动 事件（有作呕、头晕呕吐和拉稀），而标准医疗组未情况消化道道较为为严重的异常情况的必一运动 事件。

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，各种商品名克力芝，2000年获FDA核准市场销售，在改善HIV。

在之前的SARS肺炎新冠肺炎和MERS肺炎新冠肺炎暴涨后，洛匹那韦-利托那韦都充当有竟争力的诊疗中成药，但在临床药学冲击试验中，都未发生确凿的很好的举证。

针对COVID-19，洛匹那韦-利托那韦还是无效。如今的，只有看好瑞德西韦临床数据了。

就二期工程请弹框：

以上是三期监床试验报告预案：

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.