2021年12月21日，葛兰素史克（GSK）与Vir生物技术公司联合宣布，欧盟委员会（EC）已批准Xevudy（sotrovimab），用于早期治疗COVID-19。Xevudy适用于治疗：不需要补氧、有升高的风险发展为严重COVID-19的成人和青少年（年龄≥12岁，体重≥40公斤）患者。
  此次批准，基于COMET-ICE（COVID-19单克隆抗体疗效试验-早期护理意向）3期试验的数据。该试验评估了单次静脉输注（IV）sotrovimab用于有住院高风险的COVID-19患者早期治疗的疗效。主要疗效终点是发生COVID-19进展的患者比例。COVID-19进展定义为：需要住院治疗至少24小时或在随机化后29天内死亡。
  结果显示，该试验达到了主要终点：至第29天，与安慰剂相比，sotrovimab静脉治疗将全因住院超过24小时或全因死亡的风险显著降低了79%。在绝对数量方面，安慰剂组有6%（n=30/529）的患者疾病进展，sotrovimab治疗组为1%（n=6/528）。在迄今为止进行的临床试验中，sotrovimab的耐受性良好。最常见的不良反应是过敏反应和输液相关反应，分别出现在约2%和1%的患者中。
  sotrovimab是一种具有双重作用的单克隆抗体，同时具有阻断病毒进入健康细胞、清除受感染细胞的潜力。sotrovimab能够与SARS-CoV-2和SARS-CoV-1（引起SARS的病毒）共有的一个表位结合，该表位高度保守，这可能使抗药性的产生更加困难。sotrovimab融入了Xencor公司的Xtend技术，也被设计用于在肺部实现高浓度，以确保最佳穿透受SARS-CoV-2影响的气道组织，并具有延长的半衰期。
  今年5月底，美国FDA授予sotrovimab紧急使用授权（EUA），用于治疗有高风险的轻度至中度COVID-19成人和儿科患者（12岁及以上，体重至少40公斤），具体为：采用直接SARS-CoV-2病毒检测结果呈阳性、有高风险发展为严重COVID-19（包括住院和死亡）的患者。此外，sotrovimab（Xevudy）还获得了欧盟批准、获得英国附条件批准，并在多个国家获得临时批准。
  在认识到世界各地患者需求的紧迫性，GSK与Vir正在与政府和采购机构合作，提供sotrovimab以支持应对COVID-19大流行。GSK和Vir已经与世界各地的多个政府签订了供应协议，并将随着疫情的持续发展继续努力。
  GSK和Vir致力于对sotrovimab进行持续评估，这是因为COVID-19格局在全球范围内以不同的速率继续发展，并且出现了新的变体。在预印本网站bioRxiv上公布的体外数据更新表明，sotrovimab保留了所有目前已被测试的由WHO定义的受关注和感兴趣的病毒变体的活性，包括但不限于Omicron（B.1.1.529）、Delta（B.1.6172）、Delta Plus（AY.1或AY.2）和Mu（B.1.621）。
  信息来源：Xevudy (sotrovimab) granted marketing authorisation by the European Commission for the early treatment of COVID-19
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COVID-19: EMA recommends authorisation of antibody medicine Xevudy
EMA’s human medicines committee (CHMP) has recommended authorising the monoclonal antibody Xevudy (sotrovimab) for the treatment of COVID-19. The applicant is GlaxoSmithKline Trading Services Limited, who developed the medicine together with Vir Biotechnology.
The Committee recommended authorising Xevudy for treating COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) who do not require supplemental oxygen and who are at increased risk of the disease becoming severe.
Xevudy is the third monoclonal antibody recommended in the EU for treating COVID-19 and follows the approval of Regkirona and Ronapreve in November. Monoclonal antibodies are proteins designed to attach to a specific target, in this case the spike protein of SARS-CoV-2 (the virus that causes COVID-19), which the virus uses to enter human cells.
In reaching its conclusion, the CHMP eva luated data from a study involving 1,057 patients with COVID-19 showing that treatment with Xevudy significantly reduces hospitalisation and deaths in patients with at least one underlying condition putting them at risk of severe COVID-19. Following treatment with Xevudy, 1% of patients (6 out 528) were hospitalised for longer than 24 hours within 29 days of treatment compared with 6% of patients on placebo (30 out of 529), 2 of whom died.
The majority of patients in the study were infected with the original SARS-CoV-2 virus. Some patients were infected with variants including Alpha and Epsilon. Based on laboratory studies, Xevudy is also expected to be active against other variants (including Omicron).
The safety profile of Xevudy was favourable, with a small number of hypersensitivity (allergic) reactions and infusion-related reactions, and the CHMP concluded that the medicine’s benefits are greater than its risks for the approved use.
The CHMP will now send its recommendations to the European Commission for a rapid decision applicable in all EU Member States.
While the eva luation of the marketing authorisation application was underway, the Committee gave advice to assist EU Member States in deciding on the early use of this medicine. This means the medicine was already available to some patients in the EU.
More information about the eva luation of the medicine and the approved product information is available on the medicine page on EMA’s website.
https://www.ema.europa.eu/en/documents/product-information/xevudy-epar-product-information_en.pdf