Revance’s Daxxify (daxibotulinumtoxinA-lanm) Receives the US FDA’s Approval for the Treatment of Glabellar Lines in Adults
Shots:
- The US FDA has approved Daxxify for mod. to sev. frown lines (glabellar lines) in adults. The approval was based on the P-III (SAKURA) trial program i.e., (SAKURA 1/2/3) in 2700+ patients
- The results showed that 74% achieved a >2-grade improvement in glabellar lines @4wk. per investigator & patient assessment, 88% in >2-grade improvement as per investigator assessment, 98% with no or mild wrinkle severity with a median duration of 6mos. and maintained treatment results @9mos., significant improvement with long-lasting results and high patient satisfaction
- The therapy was proven to be effective, safe, and well tolerated with no serious TRAEs while the safety profile was consistent with other available neuromodulators
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