GSK’s Arexvy Receives EC’s Approval for the Prevention of Lower Respiratory Tract Disease in Individuals Aged ≥60 Years
- The EC has authorized Arexvy, the first RSV vaccine for the prevention of LRTD caused by a respiratory syncytial virus (RSV) in adults aged ≥60yrs. The company plans to launch Arexvy before the 2023/24 RSV season
- The authorisation is based on the P-III trial (AReSVi-006) evaluating Arexvy in older adults aged ≥60yrs. The trial met its 1EPs & 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, was generally well tolerated
- The vaccine was also approved in the US while regulatory reviews are ongoing in Japan & multiple other countries
Ref: GSK | Image: GSK
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