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吉利德要求取消瑞德西韦孤儿药资格

来源:Clindata 作者: 时间:2020-3-26 阅读:


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3月初,吉利德科学向FDA寻求获得孤儿药资格,开发瑞德西韦作为治疗COVID-19的潜在疗法。孤儿药资格是FDA鼓励开发治疗罕见病的措施之一,为医药公司开发在研疗法提供多种优惠政策。其中一项优惠是可以免去在新药申请前递交儿科研究计划(pediatric study plan)。这一过程的审评时间可能长达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。”

瑞德西韦是受到广泛关注的抗病毒在研疗法,它目前在6项临床试验中接受检验,治疗不同类型的COVID-19患者。其中,在中国进行的两项临床试验有望在4月份获得结果。

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的孤儿药资格认定项目旨在促进治疗罕见疾病或状况的药物或生物制品的开发。罕见疾病的定义是在美国患病人数小于20万人。获得孤儿药资格的在研疗法能够获得一系列促进药物开发的优惠,其中重要的一条是如果该疗法的孤儿药适应症获得批准,该药物可以在这一适应症方面享有7年市场独占期(exclusivity)。意味着如果FDA批准瑞德西韦用于治疗COVID-19,7年内其它医药公司开发的仿制药不能在美国上市。除此以外,在药物开发过程中,研发公司还能够获得与合格临床测试相关的税务抵免,以及递交新药申请时特定费用的减免等其它优惠。

 

吉利德科学公司开发的瑞德西韦近来成为大家关注的热点药物。它是一款抗病毒疗法,其作用机制为抑制RNA依赖性RNA聚合酶的活性,从而抑制RNA病毒的增殖。目前,吉利德公司正在进展6项临床试验,检验瑞德西韦治疗不同类型的COVID-19患者的疗效。其中,在中国进行的两项临床试验有望在4月获得结果。

 

为了满足可能出现的未来需求,该公司已经扩大瑞德西韦的生产能力,并且将生产两种瑞德西韦的配方(液体和冻干)。昨日,该公司表示,目前正在将提供个人同情使用(compassionate use)紧急通道过渡到扩展使用项目(expanded access programs),这种方法将加速重症患者获得瑞德西韦的机会,并能够收集所有参与患者的数据。这些项目目前正在与全球各国监管机构联合快速开发。


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。





2月初,旨在评估洛匹那韦-利托那韦治疗新冠的临床试验,在武汉金银潭医院开展。


试验共纳入199名新冠病毒确诊患者,随机接受常规治疗组,和常规治疗加匹那韦-利托那韦治疗。临床改善和病毒清除情况是两个关键指标,结果显示:


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。


此外,在安全性方面,洛匹那韦-利托那韦组患者出现了4起胃肠道严重不良事件(包括恶心、呕吐和腹泻),而常规治疗组未发生胃肠道严重不良事件。


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。



关于洛匹那韦-利托那韦


洛匹那韦-利托那韦,商品名克力芝,2000年获FDA批准上市,用于治疗艾滋病。


在此前的SARS疫情和MERS疫情爆发后,洛匹那韦-利托那韦都作为有潜力的治疗药物,但在临床试验中,都没有产生确凿的有效证据。

针对COVID-19,洛匹那韦-利托那韦还是无效。现在,只能期待瑞德西韦临床数据了。

关于二期请点击:刚刚!美国Remdesivir (瑞德西韦)治疗COVID-19适应性设计来了!二期拟入组394例采用7分类有序变量作为主要终点


以下是三期临床试验方案:




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.


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