Revance Therapeutics, Inc. has announced that the United States (U.S.) Food and Drug Administration has approved the first therapeutic indication for Daxxify® (DaxibotulinumtoxinA-lanm) for injection for the treatment of cervical dystonia (CD) in adults. Daxxify® was previously approved by the FDA for the temporary improvement of glabellar lines (frown lines) in adults in September 2022 and is the first true innovation in neuromodulator product formulation in more than 30 years.
Currently, there are four other commercially available botulinum toxin (BoNT) products that have FDA-approved therapeutic indications, including CD. CD is a chronic, debilitating disease that affects an estimated 60,000 people in the United States. The condition is characterized by the involuntary contraction of neck muscles, which causes abnormal movements, pain, and awkward posture of the head and neck. Neuromodulators are considered the first line of treatment for this condition; Daxxify is a peptide-formulated neuromodulator.
Daxxify’s expanded approval for CD was based on data from the Phase 3 ASPEN clinical program (ASPEN-1 and ASPEN open-label study [OLS]), which included 382 patients with moderate to severe CD. In ASPEN-1, participants received a single low dose of Daxxify (125 units), a high dose of Daxxify (250 units), or placebo.
In ASPEN-OLS, symptoms continued to improve with successive Daxxify treatments at doses of up to 300 units, while adverse events remained low. Revance expects to secure a J-code for Daxxify by the end of 2023, with broad commercial availability expected in early 2024. The annual wholesale acquisition cost for Daxxify for the treatment of CD using the recommended dose range of 125-250 units four times per year is about $3,360–$5,040.
Daxxify will compete with AbbVie’s Botox (onabotulinumtoxinA), Ipsen’s Dysport (abobotulinumtoxinA), Merz Pharmaceuticals’ Xeomin (incobotulinumtoxinA), and Solstice Neurosciences’ Myobloc (rimabotulinumtoxinB), all of which are FDA-approved for the treatment of CD.
