GSK’s RSV Vaccine Wins Expected Expansion into At-Risk Adults Aged 50-59

1. FDA Approval: The US FDA has approved GSK's Arexvy (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults aged 50-59 who are at increased risk.
2. Target Population: Approximately 13 million US adults aged 50-59 have a medical condition that increases their risk of severe RSV outcomes.
3. Medical Conditions: Adults with underlying medical conditions such as chronic obstructive pulmonary disease (COPD), asthma, heart failure, and diabetes are at increased risk for severe consequences from an RSV infection.
4. Clinical Trial: The regulatory application was supported by positive results from a phase III trial evaluating the immune response and safety of GSK's RSV vaccine in adults aged 50-59, including those at increased risk for RSV-LRTD due to certain underlying medical conditions.
5. Global Expansion: GSK has filed regulatory submissions to extend the use of its RSV vaccine to adults aged 50-59 at increased risk in Europe, Japan, and other geographies, with regulatory decisions undergoing review.
6. Future Trials: Trials evaluating the immunogenicity and safety of the vaccine in adults aged 18-49 at increased risk and immunocompromised adults aged 18 and over are expected to read out in the second half of 2024.
7. Market Impact: The FDA's expanded approval could help GSK maintain its market dominance in RSV vaccines, with the company expecting peak annual sales of over £3 billion.
8. Competition: The RSV vaccine market includes shots from Pfizer and Moderna, with GSK's Arexvy currently authorized in nearly 50 countries.