The US Food and Drug Administration (FDA) has approved daxibotulinumtoxinA-lanm injection (Daxxify) for the temporary improvement in the appearance of moderate to severe glabellar lines (frown lines) in adults.
According to a company news release, Daxxify, an acetylcholine release inhibitor and neuromuscular blocking agent, is the first peptide-formulated, long-acting neuromodulator approved for this indication.
The approval of Daxxify, manufactured by Revance Therapeutics, was based on the data from the SAKURA phase 3 clinical trial program, which included more than 2700 adults who received roughly 4200 treatments, according to the company.
About three quarters of participants achieved at least a two-grade improvement in glabellar lines at week 4 as judged by both investigator and patient and 98% achieved “none or mild wrinkle severity” at week 4 per investigator assessment, the company said.
The median duration of treatment effect was 6 months, with some patients maintaining treatment results at 9 months, compared with a 3- to 4-month duration of treatment effect with conventional neuromodulators.
“Compelling data from the largest phase 3 clinical program ever conducted for glabellar lines demonstrated that Daxxify was well tolerated and achieved clinically significant improvement with long-lasting results and high patient satisfaction,” SAKURA investigator Jeffrey Dover, MD, co-director of SkinCare Physicians, Chestnut Hill, Massachusetts, said in the news release.
“Notably,” said Dover, “Daxxify 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.”
Daxxify has a safety profile in line with other currently available neuromodulators in the aesthetics market, the company said, with no serious treatment-related adverse events reported in clinical trial participants.
The most common treatment-related adverse events in the pivotal studies were headache (6%), eyelid ptosis (2%) and facial paresis, including facial asymmetry (1%).
Daxxify is contraindicated in adults with hypersensitivity to any botulinum toxin preparation or any of the components in the formulation and infection at the injection sites.
Full prescribing information is available online.
