Revance Therapeutics received FDA approval for Daxxify to be used as an injectable to improve moderate to severe frown lines in adults.

Revance Therapeutics announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Daxxify (DaxibotulinumtoxinA-lanm) for injection for the temporary improvement of moderate to severe frown lines in adults.

Daxxify is stabilized with Peptide Exchange Technology (PXT) and is free of both human serum albumin and animal-based components.

Daxxify has the ability to address duration of treatment effect, which Revance believes is the greatest unmet need with existing neuromodulators for both consumers and injectors.

The FDA approval, Revance’s first, augments the company’s innovative aesthetics portfolio and expands the company’s access to the growing $3.2 billion U.S. facial injectables market, further establishing Revance in the industry and laying the groundwork for potential future therapeutic indications.

“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,” said Mark J. Foley, chief executive officer of Revance Therapeutics. “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.”

The U.S. approval of Daxxify was based on the data generated in the Sakura Phase 3 clinical trial program which included more than 2,700 patients and approximately 4,200 treatments. In the pivotal trials:

  • 74% of subjects achieved a two-grade improvement in glabellar lines at week 4 per both investigator and patient assessment
  • 88% achieved two-grade improvement at week 4 per investigator assessment
  • 98% of subjects achieved none or mild wrinkle severity at week 4 per investigator assessment
  • 6-month median duration
  • Some patients maintained treatment results at 9 months
  • 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 and has a safety profile consistent with other currently available neuromodulators in the aesthetics market.

The most common treatment-related adverse events observed in the pivotal trials were headache (6%) followed by eyelid ptosis (2%) and facial paresis, including facial asymmetry (1%).

“With Daxxify’s innovative and differentiated performance profile, alongside our portfolio that includes the RHA Collection of dermal fillers and the OPUL Relational Commerce platform, we have a real opportunity to build on our commercial success while setting a new standard for neuromodulator formulation,” said Dustin S. Sjuts, president of Revance. “We are excited to be launching Daxxify shortly with an early training and education program at our world-class headquarters and experience center in Nashville, followed by a broader commercial launch.”