GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has accepted for review an application to extend the indication of

GSK plc（LSE/NYSE：GSK）今天宣布，美国食品和药物管理局（FDA）已接受审查一份扩展适应症的申请。

Arexvy

阿雷克斯维

(respiratory syncytial virus (RSV) vaccine, adjuvanted) to adults aged 18-49 who are at increased risk. GSK’s RSV vaccine is approved in the US for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 and older, and for those aged 50-59 years who are at increased risk..

（呼吸道合胞病毒（RSV）疫苗，含佐剂）适用于18-49岁且感染风险增加的成年人。GSK的RSV疫苗在美国获批用于预防60岁及以上成人以及50-59岁感染风险增加的成人由RSV引起的下呼吸道疾病（LRTD）。

RSV is a common contagious virus affecting the lungs and breathing passages and impacts an estimated 64 million people of all ages globally every year.

RSV是一种常见的传染性病毒，影响肺部和呼吸道，全球每年约有6400万人受到影响。

More than 125 million adults in the US are under 50 years of age.

美国有超过1.25亿成年人年龄在50岁以下。

An estimated 21 million of these people have at least one diagnosed risk factor for severe RSV infection, such as chronic obstructive pulmonary disease (COPD), asthma, congestive heart failure and coronary heart disease (CHD).

据估计，这2100万人中至少有一项被诊断出的严重RSV感染风险因素，如慢性阻塞性肺疾病（COPD）、哮喘、充血性心力衰竭和冠心病（CHD）。

RSV can exacerbate certain medical conditions and can also lead to severe illness resulting in hospitalisation, and even death.

RSV会加重某些健康状况，导致严重疾病、住院甚至死亡。

This regulatory submission is supported by a phase IIIb trial evaluating immune response and safety in adults aged 18-49 at increased risk compared to adults aged 60 and above.

这项监管提交得到了一项 IIIb 期试验的支持，该试验评估了与 60 岁及以上成人相比，18-49 岁高风险成人的免疫反应和安全性。

The safety and reactogenicity data were consistent with results from the phase III programme that supported the initial approval of the vaccine in the US.

安全性与反应原性数据与支持该疫苗在美国最初获批的 III 期试验结果一致。

A regulatory decision by the FDA on this submission is expected in H1 2026.

预计 FDA 将在 2026 年上半年对该提交作出监管决定。

GSK is continuing to seek expanded indications for its RSV vaccine in other geographies including in the European Economic Area and Japan.

GSK继续寻求在其他地区（包括欧洲经济区和日本）扩大其RSV疫苗的适用范围。

About GSK’s RSV vaccine

关于GSK的RSV疫苗

Respiratory Syncytial Virus Vaccine, Adjuvanted, contains recombinant RSV glycoprotein F stabilised in the prefusion conformation (RSVPreF3). This antigen is combined with GSK’s proprietary AS01E adjuvant.

呼吸道合胞病毒疫苗（含佐剂）含有以预融合构象稳定的重组RSV糖蛋白F（RSVPreF3）。该抗原与GSK专有的AS01E佐剂结合。

The FDA has approved GSK’s RSV vaccine for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older, and those aged 50-59 who are at increased risk. The use of this vaccine should be in accordance with official recommendations.

美国食品药品监督管理局（FDA）已批准葛兰素史克（GSK）的呼吸道合胞病毒（RSV）疫苗，用于预防60岁及以上人群以及50-59岁高风险人群因RSV引起的下呼吸道疾病（LRTD）。该疫苗的使用应遵循官方建议。

As with any vaccine, a protective immune response may not be elicited in all vaccinees..

与任何疫苗一样，并非所有接种者都会产生保护性免疫反应。

The vaccine has been approved for the prevention of RSV-LRTD in individuals 60 years of age and older in more than 60 countries. In addition, it is approved for use in individuals aged 50-59 who are at increased risk in more than 50 markets, including the US, Japan and Europe.

该疫苗已获批准用于预防 60 岁及以上人群的 RSV-LRTD，在 60 多个国家获得批准。此外，它还获批在美国、日本和欧洲等 50 多个市场中用于有较高风险的 50-59 岁人群。

About the NCT06389487 trial

关于NCT06389487试验

NCT06389487 is a phase IIIb open-label study to evaluate the non-inferiority of the immune response and to evaluate the safety of GSK’s RSV vaccine in adults aged 18-49 at increased risk for RSV disease (n=426) compared to adults aged 60 and older (n=429). An additional cohort of 603 participants aged 18-49 were followed up for adverse events separate to safety follow up of the initial cohort.

NCT06389487是一项IIIb期开放标签研究，旨在评估GSK的RSV疫苗在18-49岁（n=426）因患RSV疾病风险增加的成年人中与60岁及以上成年人（n=429）相比的免疫反应非劣效性及安全性。此外，还对另一组603名18-49岁的参与者进行了不同于初始队列安全性随访的不良事件随访。

1,458 participants were enrolled across 52 locations in 6 countries, including 16 US sites..

1,458 名参与者在 6 个国家的 52 个地点注册，其中包括 16 个美国站点。

The trial’s co-primary endpoints were RSV-A and RSV-B neutralisation titres expressed as geometric mean titre ratio (relative to older adults over adults at increased risk) and seroresponse rate in RSV-A and RSV-B neutralising titres one month post vaccine administration. There were also safety and immunogenicity secondary endpoints. .

该试验的共同主要终点是RSV-A和RSV-B中和抗体滴度，以几何平均滴度比表示（相对于高风险成年人群中的老年人），以及疫苗接种一个月后RSV-A和RSV-B中和抗体滴度的血清反应率。此外，还有安全性和免疫原性的次要终点。

About RSV in adults

关于成人RSV

RSV is a common contagious virus affecting the lungs and breathing passages and impacts an estimated 64 million people of all ages globally every year.2 Adults can be at increased risk for RSV disease due to certain comorbidities, immune compromised status, or advanced age.5 RSV can exacerbate conditions, including COPD, asthma, and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalisation, and death.5.

RSV是一种常见的传染性病毒，影响肺部和呼吸道，全球每年约有6400万人感染此病毒。2 成人由于某些合并症、免疫功能低下或高龄，患RSV疾病的风险可能增加。5 RSV可能加重慢性阻塞性肺病（COPD）、哮喘和慢性心力衰竭等疾病，并可能导致严重后果，如肺炎、住院甚至死亡。5

About GSK

关于GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

GSK是一家全球生物制药公司，致力于联合科学、技术和人才，共同战胜疾病。欲了解更多信息，请访问gsk.com。