重磅！辉瑞新冠病毒口服药物Paxlovid，国内获附条件批准

2022-02-12 网络网络

2月11日，国家药监局根据《药品管理法》相关规定，按照药品特别审批程序，进行应急审评审批，附条件批准辉瑞公司新冠病毒治疗药物奈玛特韦片/利托那韦片组合包装(即Paxlovid)进口注册。

2月11日，国家药监局根据《药品管理法》相关规定，按照药品特别审批程序，进行应急审评审批，附条件批准辉瑞公司新冠病毒治疗药物奈玛特韦片/利托那韦片组合包装(即Paxlovid)进口注册。

适应症为：治疗SARS-CoV-2检测结果为阳性并且进展为重症Covid-19（包括住院或死亡）风险高的成人和儿童（≥12岁并且体重≥40 kg）患者的轻度至中度Covid-19。Paxlovid仅可通过处方获得，应在Covid-19诊断后症状出现5天内开始使用。

每日2次，每次口服3片（2片奈玛特韦和1片利托那韦），连续5天，共30片。Paxlovid不能连续使用超过5天。

本品为口服小分子新冠病毒治疗药物，用于治疗成人伴有进展为重症高风险因素的轻至中度新型冠状病毒肺炎(COVID-19)患者，例如伴有高龄、慢性肾脏疾病、糖尿病、心血管疾病、慢性肺病等重症高风险因素的患者。Paxlovid不建议用于重度肾损伤或重度肝损伤患者。在中度肾损伤患者中，需要降低Paxlovid剂量。对于有肾脏或肝脏问题的患者，应当与其医师讨论Paxlovid是否适合这些患者。患者应在医师指导下严格按说明书用药，使用中应高度关注说明书中列明的与其他药物相互作用信息。

国家药监局要求上市许可持有人继续开展相关研究工作，限期完成附条件的要求，及时提交后续研究结果。

在EPIC-HR研究中，奈玛特韦与CYP3A抑制剂利托那韦联合使用，可将确诊轻度至中度Covid-19的未接种疫苗的高危成人门诊患者的住院率或全因死亡率降低近90%。关于已接种疫苗标准风险成人疗效的研究正在进行中。详细：辉瑞新冠特效药Paxlovid预防死亡效力高达89%！

Paxlovid不得用于Covid-19暴露前或暴露后预防，也不得用于因Covid-19需要住院的重症或危重症患者的初始治疗。对于建议接种Covid-19疫苗和加强剂量的个人，Paxlovid不是疫苗接种的替代品。

奈玛特韦（nirmatrelvir）（商品名Paxlovid，辉瑞）是一种病毒蛋白酶抑制剂，可以抑制SARS-CoV-2蛋白，阻止病毒复制，而利托那韦可以减缓奈玛特韦分解，帮助它在较高浓度下较长时间地留在体内。Paxlovid由奈玛特韦和利托那韦组成，对迄今为止所有临床重要的SARS-CoV-2变异株具有体外活性。

支持Paxlovid此次EUA的主要数据来自EPIC-HR。EPIC-HR是一项随机、双盲、安慰剂对照2/3期临床试验，对Paxlovid治疗经实验室确诊为SARS-CoV-2感染的非住院有症状成人患者进行了研究。

患者为有预先设定进展为重症危险因素的≥18岁成人，或者≥60岁（不论是否有预先设定的慢性疾病）。所有患者既往未接种过Covid-19疫苗，并且既往未感染过Covid-19。研究共纳入2246名患者，按1:1随机分配至Paxlovid组（1,039例患者）或安慰剂组（1,046例患者）。

主要终点是对于症状出现3天内服药并在28天随访期间因Covid-19住院或任何原因死亡的患者比例，次要终点是症状出现5天内服药的上述比例。

在症状发生后3天内接受治疗并且未接受Covid-19治疗性单克隆抗体治疗的患者中，Paxlovid使Covid-19相关住院或任何原因死亡的患者比例显著降低了89%。症状发生后5天内接受治疗患者的上述比例下降88%。在这些患者中，0.8%的Paxlovid组患者和6%的安慰剂组患者在28天随访期间住院或者死亡。Paxlovid治疗Covid-19的安全性和有效性仍在继续接受评估。

见：辉瑞新冠口服药物Paxlovid降低住院或死亡率89%！即使是出现症状5天内，仍然极其有效！

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2022-04-23 智慧医人

#口服药物#

114 0
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2022-09-12 gdsun

#口服药#

98 0
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2022-02-14 12346c4dm64暂无昵称

新冠药物

112 0
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2022-02-14 xxxx1054

#重磅#

90 0
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2022-02-13 学医无涯

了解一下

116 0
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2022-02-12 12346c4dm64暂无昵称

希望来了

130 0
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2022-02-12 医者仁者

国内应该开放辉瑞的mRNA疫苗，国内的#灭活疫苗#差距还是十分大的，就算是#沃森#的mRNA疫苗，现在看来差距也很大，其副作用高到难以接受的地步！开放辉瑞#mRNA疫苗#进入国内，也是正途呀

171 0
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2022-02-12 医者仁者

特效药物的开放，更关心在国内的订价，如果一个疗程在1000元以内的话，国内就可以完全放开了

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