FDA approves Daxxify for glabellar line improvement

The FDA has approved the neuromodulator injection Daxxify for the temporary improvement of moderate to severe glabellar lines, Revance Therapeutics Inc. announced in a press release.

Daxxify (DaxibotulinumtoxinA-lanm) is the first neuromodulator stabilized with Peptide Exchange Technology and is free of human serum albumin and animal-based components.

The approval was based on data from the SAURA phase 3 clinical trial program in which 74% of patients achieved a 2-grade or more improvement in glabellar lines at week 4 as assessed by both investigator and patients, and 88% achieved a 2-grade or more improvement at week 4 per investigator assessment.

The effects had a median duration of 6 months, with some patients maintaining results for up to 9 months.

“Compelling data from the largest phase 3 clinical program ever conducted for glabellar lines demonstrated that Daxxify was well tolerated and achieved clinically significant improvement with long-lasting results and high patient satisfaction,” Jeffrey Dover, MD, co-director of SkinCare Physicians of Chestnut Hill and one of the study’s investigators, said in the release. “Notably, Daxxify was able to demonstrate a long duration of effect while only utilizing 0.18 ng of core active ingredient in the 40-unit labeled indication for glabellar lines.

“With today’s approval, I look forward to helping patients, who have been accustomed to a 3- to 4-month duration profile with conventional neuromodulators, achieve year-long results with as few as two treatments per year,” Dover said.