The FDA has approved daxibotulinumtoxinA-lanm (Daxxify, Revance Therapeutics Inc), an injection for the temporary improvement of moderate to severe frown lines, or glabellar lines, in adults.

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

“The FDA approval of [daxibotulinumtoxinA-lanm] is a foundational achievement for the company, as it marks the culmination of years of pioneering research and development made possible by the outstanding execution of our talented team, along with strong support from the medical and investor communities,” Mark Foley, CEO of Revance Therapeutics, said in a statement. “Importantly, we are very pleased [daxibotulinumtoxinA-lanm]’s label includes data demonstrating the achievement of none or mild wrinkle severity based on investigator and subject assessments, as this provides the foundation for our marketing claims around duration of effect.”

Additionally, daxibotulinumtoxinA-lanm can address the duration of the treatment effect, which is considered an unmet need within existing neuromodulators for both consumers and injectors, according to the statement.

The FDA approval was based on data from the SAKURA phase 3 clinical trial program, which included more than 2700 individuals with approximately 4200 treatments.

Approximately 74% of individuals received a 2-grade or greater improvement in glabellar lines at week 4, according to both investigator and patient assessments, with 88% achieving the improvement per investigator assessment.

Additionally, 98% of individuals achieved mild or no wrinkle severity at week 4, according to investigators’ assessment.

There was a 6-month median duration, and some individuals maintained their results at 9 months. The results were also seen as early as 1 day after treatment but typically were seen within 2 days.

“Compelling data from the largest phase 3 clinical program ever conducted for glabellar lines demonstrated that [daxibotulinumtoxinA-lanm] was well tolerated and achieved clinically significant improvement with long-lasting results and high patient satisfaction. Notably, [daxibotulinumtoxinA-lanm] 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, said in the 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 said.

DaxibotulinumtoxinA-lanm was generally safe and well tolerated, with no serious treatment-related adverse events (TRAEs) reported in the clinical trial program.

It has a consistent safety profile compared with other available neuromodulators in the aesthetics market, according to the statement.

The most common TRAEs with daxibotulinumtoxinA-lanm were eyelid ptosis; facial paresis, including facial asymmetry; and headaches.

The FDA approval was the company’s first in the aesthetic market, which is a growing $3.2 industry in the United States, according to the statement.

This paves the way for potential future therapeutic indications, the company said.

Reference

Revance announces FDA Approval of Daxxify (daxibotulinumtoxinA-lanm) for injection, the first and only peptide-formulated neuromodulator with long-lasting results. News release. Businesswire. September 8, 2022. Accessed September 12, 2022. https://www.businesswire.com/news/home/20220908005320/en