GSK expands Arexvy indication in Japan to adults aged 18–49 at increased risk for RSV, including immunocompromised patients, supported by Phase IIIb and Phase IIb trial data.
Written By: Sana Khan, BPharm
Reviewed By: Pharmacally Editorial Team
GSK announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has expanded the indication for Arexvy to include adults aged 18 to 49 years who are at increased risk of respiratory syncytial virus (RSV) disease.
The vaccine was previously approved in Japan for adults aged 60 years and older, as well as adults aged 50 to 59 years who are at increased risk for RSV disease. The prescribing information has also been updated to explicitly include immunocompromised patients as an at-risk group that may benefit from RSV prevention.
Sanjay Gurunathan said the expanded indication marks the first RSV vaccine approval in Japan covering all at-risk adults. He noted that RSV can lead to severe outcomes in adults living with chronic conditions such as cardiovascular disease, chronic obstructive pulmonary disease (COPD), and asthma, and said the broader label may help more people take a proactive approach to disease prevention.
RSV is a common respiratory virus that can cause serious illness in adults, particularly those with underlying medical conditions. According to GSK, RSV infection may trigger major adverse cardiovascular events such as heart attack and stroke, worsen COPD and asthma, and lead to hospitalization or death in severe cases. More than 42 million adults in Japan are aged 18 to 49 years, a population in which many individuals live with chronic conditions that may increase the risk of severe RSV disease.
The expanded indication was supported by results from the Phase IIIb NCT06389487 trial, which demonstrated a non-inferior immune response in adults aged 18 to 49 years at increased risk for RSV disease compared with adults aged 60 years and older. Vaccine efficacy had previously been demonstrated in the Phase III NCT04886596 trial.
The safety profile observed in the Phase IIIb study was consistent with earlier Phase III findings. The most commonly reported adverse events included injection site pain, myalgia, fatigue, arthralgia, and headache, which were generally mild to moderate and transient.
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) also accepted updated prescribing information to include immunocompromised patients based on data from the Phase IIb NCT05921903 study. That study evaluated the vaccine in adults who had received lung or kidney transplants and were considered at increased risk for severe RSV-related lower respiratory tract disease.
GSK stated that it continues to pursue regulatory submissions globally to expand access to its RSV vaccine and support broader disease prevention efforts. The Japan expansion aligns with similar regulatory approvals already granted in the United States for at-risk adults aged 18 to 49 years and in the European Economic Area for adults aged 18 years and older.
Arexvy contains a recombinant RSV glycoprotein F antigen stabilized in the prefusion conformation and is combined with GSK’s proprietary AS01E adjuvant system. The vaccine is approved in more than 70 countries for adults aged 60 years and older and in more than 60 countries for adults aged 50 to 59 years at increased risk due to underlying conditions
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About the Writer
Sana Jamil Khan (LinkedIn) is a B. Pharm graduate with a strong interest in medical writing and scientific communication. Her work focuses on interpreting clinical research, exploring developments in pharmaceutical science, and presenting complex medical information in a clear and accessible manner. She is particularly interested in topics related to human clinical studies, drug safety observations, and emerging therapeutic research.