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Japan’s MHLW Grants Expanded Indication Approval to GSK’s RSV Vaccine, Arexvy

23 Nov 2024
Admin
News Article

Japan’s MHLW Grants Expanded Indication Approval to GSK’s RSV Vaccine, Arexvy

Japan’s MHLW grants expanded indication approval to GSK’s RSV vaccine, Arexvy for adults aged 50-59 at increased risk of severe RSV disease

Overview

GSK plc announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved a regulatory application to extend the indication of Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) for the prevention of RSV disease to include adults aged 50-59 at increased risk. Since September 2023, GSK’s RSV vaccine has been approved in Japan for adults aged 60 and over for the prevention of RSV disease.

Words from the CSO: GSK

Tony Wood, chief scientific officer at GSK, said: ""This approval reflects our ambition to protect people at increased risk from the severe consequences of RSV infection. Adults aged 50-59 with certain underlying medical conditions can face debilitating consequences from RSV, so we are pleased to offer those in Japan a vaccine for the first time.”

About RSV

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

Behind Global Expansion: Global Phase III Trial

This regulatory expansion was supported by results from a global phase III trial (including 4 clinical sites in Japan) that showed non-inferior immunogenicity in adults aged 50-59 at increased risk of RSV lower respiratory tract disease compared to those aged 60 and older.
Safety and reactogenicity in the 50-59 at increased risk population were consistent with results from the initial phase III programme in adults aged 60 and older.

RSV vaccine approvals- To date, GSK’s RSV vaccine has been approved for adults aged 50-59 at increased risk in 35 countries, including the US, with regulatory decisions for other geographies undergoing review.

The Antigen

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

MHLW Approval for RSV Vaccine

In September 2023, the MHLW approved GSK’s RSV vaccine for the prevention of RSV (respiratory syncytial virus) disease for adults aged 60 years and above in Japan.
The use of this vaccine should be in accordance with official recommendations.
As with any vaccine, a protective immune response may not be elicited in all vaccinees.

AS01 Adjuvant System

The GSK proprietary AS01 adjuvant system contains STIMULON QS-21 adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc.
STIMULON is a trademark of SaponiQx Inc., a subsidiary of Agenus.

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together.