Revance Therapeutics announces positive phase 2 DAXI results and provides an update on expected FDA Approval.
Revance Therapeutics, an aesthetic and therapeutic biotechnology company, recently announced positive results from its phase 2 multicenter, open-label study of DaxibotulinumtoxinA (DAXI) for the injectable treatment of glabellar lines, dynamic forehead lines, and lateral canthal lines.
This comes as the medical aesthetic community waits for news on FDA approval for DAXI, which was initially expected in November 2020.
“Revance is currently awaiting a decision on the approval of DaxibotulinumtoxinA for Injection for the treatment of glabellar lines by the U.S. Food and Drug Administration, pending a manufacturing site inspection, which was delayed due to COVID-19 travel restrictions,” according to the release.
The study enrolled 48 subjects over a duration of 36 weeks, each of whom received a single treatment of 40 units DAXI in the glabella, 32 units in the forehead, and 48 units split between the lateral canthi.
At week four, 100% of participants reported being at least “somewhat satisfied’ with the treatment in all three areas using a 7-point Subject Global Satisfaction with Treatment Questionnaire. A total of 83%, 78.7%, and 80.9% of participants reported being “very satisfied” with the treatment of their glabellar lines, forehead lines, and lateral canthal lines, respectfully.
“Many of my patients are looking for a more enduring treatment of their upper facial lines and wrinkles, as currently available neuromodulators typically only last 10 to 16 weeks, depending on the location within the face,” says study investigator Jeffrey S. Dover, M.D., FRCPC, co-director of SkinCare Physicians in Chestnut Hill, Mass, in the release. “I am pleased to see the high patient satisfaction scores for DaxibotulinumtoxinA for Injection and expect a treatment regimen of just two times a year could be a welcome benefit to patients looking for long-lasting treatment.”
Study investigators conclude that DAXI is generally safe for injection and well-tolerated when used in all three facial areas simultaneously. No treatment-related serious adverse events were reported and the most common adverse events were injection site erythema (6.3%), facial discomfort (4.2%), and headache (2.1 %).
This phase 2 study builds on two phase 2a open-label, dose-escalation studies of DAXI for injection of forehead lines following glabellar line and lateral canthal line injections. The interim week 4 data from the phase 2a studies were used in the final design of the phase 2 study to optimize dosing and injection patterns, according to Revance.
“This full upper face data complements our already reported results from individual dose-ranging studies, and further expands the body of knowledge on our next-generation neuromodulator,” says Roman Rubio, M.D., senior vice president of clinical development at Revance. “As we saw in our other aesthetic and therapeutic clinical trials, DaxibotulinumtoxinA for Injection delivered a meaningful duration of effect, ranging from 24 to 35 weeks, depending on the measure used and indication studied, while being generally well tolerated by patients.”
In addition to its Phase 2 study results, Revance also announced a strategic commercial manufacturing agreement with Ajinomoto Bio-Pharma Services for the supply of DAXI.
Aji Bio-Pharma will serve as a dual supply source and provide drug product manufacturing services at Revance’s aseptic manufacturing facility in San Diego, Calif.
"We are excited to partner with Revance and their efforts to establish a new standard in aesthetic and therapeutic neuromodulator offerings," says Jean-Baptiste Agnus, VP of sales at Ajinomoto Bio-Pharma Services. "This partnership underscores our commitment to be a leading, trusted, innovative partner to our clients and reinforces our company mission to improve the health of humankind."