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The phase 3 trial of Arexvy involved 1,576 subjects and was designed to demonstrate non-inferiority in the younger age group compared to those over 60. GSK’s chief scientific officer, Tony Wood, expressed confidence in Arexvy’s potential to protect adults aged 50-59 at increased risk for RSV-related lower respiratory tract disease (RSV-LRTD).
Currently approved for use in over-60s, GSK is preparing FDA filings to expand Arexvy’s label by next year. This move could create a separate market segment from Pfizer’s Abrysvo, another FDA-approved RSV vaccine that also functions as a maternal vaccine. Both vaccines are recommended by the Advisory Committee on Immunization Practices (ACIP) for the upcoming RSV season.
Simultaneously, Pfizer (NYSE:PFE) is conducting a phase 3 trial of Abrysvo involving 675 subjects who are at higher risk of RSV disease due to chronic medical conditions. The competition between these two pharmaceutical giants underscores the importance of this segment in the global health market.
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