Shots:
- The Japanese MHLW has approved GSK‘s Arexvy RSV vaccine for adults (18-49yrs.) at increased risk for RSV disease, expanding its use beyond those aged ≥50yrs.
- Approval was based on P-IIIb trial (n=1458) assessing Arexvy in individuals (18-49yrs.; n=426) compared to adults (≥60yrs.; n=429), which showed a non-inferior immune response in individuals (18-49yrs.) who are at increased risk of RSV disease compared to adults (≥60yrs.)
- Also, the prescribing information for Arexvy has been updated to incl. immunocompromised patients as an at-risk group for RSV, following acceptance by PMDA, supported by P-IIb trial data
Ref: GSK | Image: GSK | Press Release
Related News: The US FDA Grants Priority Review and Breakthrough Therapy Designation to GSK’s Bepirovirsen for Chronic Hepatitis B
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