GSK Expands Arexvy Approval to Adults Aged 50-59 at Increased Risk of Severe RSV Disease in Japan

GSK has announced the approval by Japan’s Ministry of Health, Labour and Welfare (MHLW) to extend the indication of Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) for the prevention of respiratory syncytial virus (RSV) disease to adults aged 50-59 who are at an increased risk due to certain underlying health conditions. Following its authorization in Japan last year for individuals aged 60 and above, the current approval now extends to include individuals in their fifties.

RSV Affects 64 Million Worldwide; Increased Risk in the Elderly Populations

RSV is a highly contagious virus that affects the lungs and respiratory passages, leading to serious complications, particularly in vulnerable populations. For adults, certain pre-existing conditions such as chronic obstructive pulmonary disease (COPD), asthma, and heart failure can make RSV infections more severe, resulting in pneumonia, hospitalization, and even death. The newly expanded approval offers an essential option to adults in the designated age range who face a heightened risk of these outcomes due to such health conditions.

Globally, RSV affects an estimated 64 million people annually across all age groups. The clinical burden of RSV in these individuals is substantial, making prevention a critical healthcare priority. Tony Wood, Chief Scientific Officer at GSK, highlighted the importance of this development by stating, “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.”

Expanding Access to GSK’s RSV Vaccine: A Key Step in Combating a Deadly Virus with Official Health Recommendations in Japan

GSK’s vaccine approval was based on robust data from a global phase III trial (AReSVI-006), which included clinical sites in Japan. The trial demonstrated that the vaccine provided non-inferior immunogenicity in adults aged 50-59 at increased risk when compared to those aged 60 and above. Furthermore, the safety profile for the 50-59 age group was consistent with the results from the initial studies conducted in older adults. Additionally, it has already been approved in 35 countries, including the United States, with regulatory reviews currently underway in additional regions.

RSV remains a major public health challenge, especially for vulnerable populations. With the expanded approval of Arexvy, GSK aims to provide tools to help reduce the burden of this potentially deadly virus in Japan, offering hope for individuals at high risk. The vaccine is expected to be administered in accordance with official health recommendations, and as with any vaccine, individual responses may vary. Detailed safety information will be available from the Japan Pharmaceuticals and Medical Devices Agency.

Arexvy is a Combination of Recombinant RSV Glycoprotein F and AS01E Adjuvant

GSK’s respiratory syncytial virus vaccine, Arexvy, contains recombinant RSV glycoprotein F, stabilised in the prefusion conformation (RSVPreF3), combined with GSK’s proprietary AS01E adjuvant system. This combination enhances the immune response and provides protection against RSV infection in at-risk populations.

In addition to Arexvy, other RSV vaccines are also addressing the global burden of this virus. In 2023, RSV vaccines were approved, including a maternal vaccine targeting the RSV prefusion protein and a market-approved long-acting monoclonal antibody. These developments aim to significantly decrease hospitalisation rates and mortality, particularly in high-risk infants, and may play a crucial role in worldwide RSV prevention efforts. As more preventive strategies emerge, the global healthcare community is looking to implement these vaccines in regions with the greatest need, including low- and middle-income countries. 

Author

Denisse Sandoval