Tony Hagen is senior managing editor for The Center for Biosimilars®.
DaxibotulinumtoxinA met all end points in a study demonstrating longer duration of action, safety, and tolerability.
As Revance and Mylan move forward with a joint plan to obtain FDA approval for a biosimilar onabotulinumtoxinA referencing Botox (AbbVie), Revance announced positive phase 3 clinical trial results for its daxibotulinumtoxinA (Daxi) injectable, which also would compete with Botox by offering patients longer duration of drug activity and, consequently, fewer trips to the physician for injections.
Revance, of Newark, California, reported positive efficacy, safety, and tolerability findings for the daxibotulinumtoxinA injectable from the ASPEN-1 trial, supporting the concept of reduced physician visits and drug efficacy longevity with this agent.
DaxibotulinumtoxinA is intended for the treatment of cervical dystonia, a chronic neurological condition that causes abnormal movements and awkward posture of the head and neck. Frontline treatment is usually a neuromodulator, such as onabotulinumtoxinA.
Revance said daxibotulinumtoxinA was found to be safe and tolerable in a population of 301 patients randomized to single treatments of 125 or 250 units of daxibotulinumtoxinA or placebo. The study duration was 36 weeks.
In addition, Revance said patients treated at either dose level achieved a clinically meaningful improvement in cervical dystonia by the fourth and sixth weeks. As measured on the Toronto Western Spasmodic Torticollis Rating Scale, statistically significant improvements were noted in patients who received either the 125- or 250-unit doses (12.7 and 10.9, respectively, vs 4.3 [placebo]; P < .0001 and P = .0006).
The median durations of response were 24.0 and 20.3 weeks for the 125- and 250-unit doses, respectively.
“Currently, most patients with cervical dystonia visit their physician 3 to 4 times a year for injections, which places a heavy burden on patients’ time and schedule,” said trial investigator Joseph Jankovic, MD, a professor of neurology and founder and director of The Parkinson's Disease Center and Movement Disorders Clinic at Baylor College of Medicine in Houston, Texas.
“Often, the treatment effect wears off between injections, significantly impacting the quality of their work and personal lives. If a treatment could offer longer duration of effect, thus requiring fewer trips each year for reinjection, I imagine patients would find this quite beneficial,” Jankovic said.
The ASPEN-1 findings improve Revance’s shot at the $5.1 billion global neuromodulator market, said Mark Foley, president and CEO at Revance.
“We are very pleased to report these positive results from the ASPEN-1 phase 3 trial, as this is the company’s second successful phase 3 program demonstrating daxibotulinumtoxinA for injection’s extended duration profile, now across 2 different treatment categories: aesthetics and therapeutics,” Foley said. “In addition to laying the foundation for our therapeutics franchise, these results reinforce its potential in other muscle movement and pain disorders.”
In February 2020, Revance said the FDA had accepted its biologics license application for daxibotulinumtoxinA for the treatment of moderate to severe glabellar (frown) lines. The drug received an FDA orphan drug designation in 2017 for the treatment of cervical dystonia. Orphan drug status confers tax reductions and other advantages designed to spur development of innovative products.