The US FDA Rejects Dynavax’ Four-Dose Heplisav-B Regimen for Adults on Hemodialysis
Shots:
- The US FDA issued a Complete Response Letter (CRL) for the four-dose Heplisav-B vaccine's sBLA. It does not affect vaccine approval across the US, EU & Great Britain plus the EC’s decision for adults on hemodialysis
- The sBLA was based on immunogenicity & safety results from the P-I (HBV-24) trial assessing a four-dose regimen of Heplisav-B in adults (n=119) on hemodialysis and 5 other Heplisav-B studies in CKD adults on hemodialysis
- The CRL mentioned that the results were insufficient due to the destruction of source documents by a third-party study site operator for ~50% of enrolled individuals & the total no. of individuals across the single-arm HBV-24 study was considered inadequate for its safety assessment
Ref: Dynavax | Image: Dynavax
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.