June 7,GSK announced that the FDA has approvedThe scope of the recombinant Respiratory Syncytial Virus (RSV) vaccine Arexvy has been expanded to include adults aged 50-59 who are at high risk for RSV. This is the first vaccine offering protection.50-59RSV vaccine for high-risk populations.Arexvy has been approved for marketing in the United States and Europe in 2023, respectively, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and above.As the world's first marketed RSV vaccine,Arexvy's sales performance has been quite impressive, generating 12.38 billion in just 9 months after its launch.GBP billion (approximately USD 15.45 billion) in revenue, quickly joining the list of "blockbuster" drugs.This expansion of the applicable population is based on positive results from a Phase III placebo-controlled, randomized study (NCT05590403). The trial aimed to evaluate the non-inferiority and safety of the immune response in participants aged 50-59 with an increased risk of RSV-LRTD compared to adults aged 60 and above after a single dose of Arexvy.The results showed that the immune response in the 50-59 age group was non-inferior to that in the 60 and above age group, meeting the primary endpoint. In addition, the study also achieved secondary and tertiary endpoints for safety and immunogenicity.RSV Vaccine Track, BesidesGSK's Arexvy and Pfizer's Abrysvo were successively approved for marketing last year, and after a year,Moderna'sRSV VaccinemRESVIA has also been recently approved for marketing, joining the RSV vaccine race.Copyright © 2024 PHARMCUBE. All Rights Reserved.
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