Key Contribution
ADVERSE EVENTS
DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A product containing daxibotulinumtoxinA with a stabilizing excipient peptide (RTP004). DAXI immunogenicity was assessed in three phase 3 glabellar line studies (two placebo-controlled, single-dose studies and an open-label repeat-dose safety study). Binding antibodies to daxibotulinumtoxinA and RTP004 were detected by validated ELISAs. Samples positive for daxibotulinumtoxinA-binding antibodies were evaluated further for titer and neutralizing antibodies by mouse protection assay. Overall, 2786 subjects received DAXI and 2823 subjects were exposed to RTP004 as DAXI (This multi-study evaluation of the risk of anti-drug antibody formation to DaxibotulinumtoxinA for Injection (DAXI) in a large clinical trial program indicates low rates of antibody formation to the core neurotoxin daxibotulinumtoxinA and the unique excipient peptide RTP004, with negligible impact on DAXI efficacy or immune-related adverse events.