FDA Approves Longer-Lasting Treatment for Frown Lines

The FDA has approved Daxxify (daxibotulinumtoxinA-lanm) for injection for the temporary improvement of moderate-to-severe frown lines (glabellar lines) in adults. Developed by Revance Therapeutics, Daxxify is an acetylcholine release inhibitor and neuromuscular blocking agent stabilized with the company’s Peptide Exchange Technology. It is free of both human serum albumin and animal-based components.

Jeffrey Dover, M.D.

“With this approval, I look forward to helping patients, who have been accustomed to a three to four-month duration profile with conventional neuromodulators, achieve year-long results with as few as two treatments per year, investigator Jeffrey Dover, M.D., co-director of SkinCare Physicians of Chestnut Hill in Massachusetts, said in a press release.

The approval was based on the data generated in the SAKURA phase 3 clinical trial program (SAKURA 1,2,3), which included more than 2,700 patients and about 4,200 treatments. In the pivotal trials, 74% of subjects achieved a > two-grade improvement in glabellar lines at week four per both investigator and patient assessment, and 98% of subjects achieved none or mild wrinkle severity at week 4 per investigator assessment. The median duration of effort was six months. Some patients maintained treatment results at nine months, with results seen as early as one day after treatment, typically seen within two days.

Daxxify is generally safe and well tolerated with no serious treatment-related adverse events reported in the clinical trials. The most common treatment-related adverse events with were headache followed by drooping of the upper eyelid ptosis and facial paresis (the inability to move facial muscles), including facial asymmetry.

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