Five months after GSK made history by securing FDA approval for its respiratory syncytial virus (RSV) vaccine, Arexvy, the company is now actively pursuing an expansion of its approved age group. GSK’s recent announcement reveals that a study examining Arexvy’s effectiveness in adults aged 50 to 59 has successfully met its two primary objectives, setting the stage for potential approval for this age bracket. The FDA had already given its green light for Arexvy’s use in individuals aged 60 and above.
The study found that in adults aged 50 to 59 who face an elevated risk of RSV lower respiratory tract disease due to underlying health conditions, Arexvy elicited an immune response that was non-inferior to those aged 60 and older. The study also showed that Arexvy met the same efficacy standards for those in the 50 to 59 age group without underlying health conditions. GSK’s Chief Scientific Officer, Tony Wood, expressed the company’s intention to promptly submit these promising results for regulatory review with the aim of offering adults in the 50 to 59 age category access to a vaccine option.
Also Read: GSK’s Arexvy Takes Lead In RSV Vaccine Race, Now Accessible At Leading US Pharmacies
Additionally, GSK is set to present these results at the CDC’s Advisory Committee on Immunization Practices (ACIP) meeting. The company has its sights set on a label expansion in the US in 2024.
GSK originally gained FDA approval for Arexvy following a trial demonstrating its 82.6% efficacy against RSV and a remarkable 94.1% effectiveness in preventing severe disease. Shortly thereafter, Pfizer received FDA clearance for its RSV bivalent vaccine, Abrysvo, intended for adults aged 60 and above. Pfizer’s RENOIR trial displayed 66.7% protection against RSV and an 85.7% efficacy in preventing severe disease.
Three months later, the FDA extended its approval of Abrysvo to women in their 32nd to 36th week of pregnancy, offering protection to their infants through the first six months of life.
Also Read: GSK Lowers Short-Term Hopes For RSV Treatment Arexvy But Raises 2023 Forecast
This development followed the FDA’s approval of Sanofi and AstraZeneca’s Beyfortus in July as a preventive measure for RSV lower respiratory tract disease in infants entering their first RSV season and those remaining vulnerable for their second RSV season.
In July, a report from GlobalData predicted that GSK would emerge as the market leader in the RSV sector, with the overall market expected to reach $9 billion by 2029. The analysis also indicated that Moderna, currently developing an mRNA vaccine for RSV, would closely follow GSK in this competitive landscape.
