GSK’s Arexvy Receives the US FDA’s Approval for the Prevention of Lower Respiratory Tract Disease in Individuals Aged ≥60 Years
- The US FDA has approved Arexvy, the first RSV vaccine for the prevention of LRTD caused by a respiratory syncytial virus in individuals aged ≥60yrs.
- The approval was based on the P-III trial (AReSVi-006) evaluating Arexvy. The trial met its 1EPs i.e., the results showed an overall vaccine efficacy of 82.6% against RSV-LRTD in adults aged ≥60yrs.; efficacy was 94.6% in older adults with one underlying medical condition of interest, 94.1% efficacy against sev. RSV-LRTD
- The vaccine was found to be well tolerated with an acceptable safety profile & is expected to be available for older adults before the 2023/24 RSV season. Additionally, regulatory reviews are ongoing in Japan & multiple other countries
Ref: GSK | Image: GSK
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