GSK’s Arexvy Receives the US FDA’s Approval for the Prevention of Lower Respiratory Tract Disease in Individuals Aged ≥60 Years
Shots:
- 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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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
