Daxxify from Revance Gets FDA Greenlight

Daxxify™ (DaxibotulinumtoxinA-lanm) from Revance is FDA approved for the temporary improvement of moderate to severe frown lines (glabellar lines) in adults. Daxxify is the first and only neuromodulator stabilized with Peptide Exchange Technology™ (PXT) and is free of both human serum albumin and animal-based components. 

The approval is the first for Revance, which says  Daxxify has the ability to address duration of treatment effect.

“The FDA approval of Daxxify 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. It has been an incredible and rewarding journey to realize our vision and bring this disruptive innovation to an industry that has remained largely unchanged for over 30 years,” says Mark J. Foley, Chief Executive Officer. “Importantly, we are very pleased Daxxify’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. We look forward to continuing to set new standards in aesthetics and to establishing a new category of long-lasting, peptide-enhanced neuromodulators.” Daxxify is generally safe and well tolerated with no serious treatment-related adverse events reported in the clinical trials and has a safety profile consistent with other currently available neuromodulators in the aesthetics market. The most common treatment-related adverse events with Daxxify observed in the pivotal trials were headache (6%) followed by eyelid ptosis (2%) and facial paresis, including facial asymmetry (1%).