The US Food and Drug Administration (FDA) has approved Revance Therapeutics’ Daxxify (DaxibotulinumtoxinA-lanm) for injection to temporarily improve moderate to severe frown lines (glabellar lines) in adults.
Daxxify for injection is a neuromuscular blocking agent and an acetylcholine release inhibitor, which is indicated to temporarily improve moderate to severe glabellar lines’ appearance related to corrugator and/or procerus muscle activity in adult patients.
Powered by Peptide Exchange Technology (PXT), Daxxify is claimed to be the first and only FDA approved long-lasting peptide-formulated neuromodulator product for adults.
Additionally, the product can address the time taken for the treatment to show effect.
The regulatory approval was based on the data obtained from the SAKURA Phase III clinical trial programme (SAKURA 1,2,3) that was conducted in over 2,700 patients and included nearly 4,200 treatments.
In the pivotal trials, 74% of the participants achieved a > two-grade improvement in glabellar lines at week-4 per investigator and patient assessment.
At week-4 per investigator assessment, 88% of them achieved more than two-grade improvement and 98% achieved none or mild wrinkle severity.
Revance Therapeutics CEO Mark Foley said: “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.
“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.”
Headache, eyelid ptosis, facial paresis including facial asymmetry are the most common treatment-related adverse events observed in the trials.