FDA Approves Botox Alternative Daxxify for Glabellar Lines

With support from the phase 3 SAKURA clinical program, daxibotulinumtoxinA-lanm (Daxxify) was granted approval by the FDA for the temporary treatment of glabellar lines, or moderate to severe frown lines, in adults. It's the first and only neuromodulator stabilized with Peptide Exchange Technology (PXT).

According to Revance Therapeutics, the injectible treatment addresses the duration of treatment effect—a need that's not been met by existing neuromodulators for both consumers and injectors.

"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," Jeffrey Dover, MD, co-director of SkinCare Physicians of Chestnut Hill, and study investigator said in a statement.

"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 2 treatments per year," he explained.

The SAKURA phase 3 clinical trial program included more than 2700 patients and approximately 4200 treatments. A 2-grade improvement in glabellar lines or higher was achieved in 74% of patients after 4 weeks, according to investigator and patient assessment.

The investigator assessment alone reported this improvement occurred in 88% of patients. Mild or no wrinkle severity was observed by investigators in 98% of the population at week 4.

Results were typically apparent within 2 days, though some saw results as early as the first day post-treatment. The median duration was 6 months, but when evaluated at 9 months, some patients had maintained results.

“As a SAKURA investigator, I’m pleased to see Daxxify now approved as the first and only peptide-formulated, long-acting neuromodulator in the market," Dover said. "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."