Daxxify Receives FDA Approval to Treat Cervical Dystonia
The Food and Drug Administration has approved Daxxify (DaxibotulinumtoxinA-lanm; Revance Therapeutics, Nashville, TN) for its first therapeutic indication for injection to treat cervical dystonia in adults. Daxxify was previously approved for injection to temporarily reduce the appearance of moderate to severe glabellar lines.
The approval is based on data from the phase 3, masked, randomized clinical program comprising ASPEN-1 (NCT03608397) and the open-label study (OLS), ASPEN-OLS (NCT03617367) showing safety and effectiveness of treatment of cervical dystonia with Daxxify. In the double-blind, 36-week study ASPEN-1, 382 adult participants who met diagnostic criteria for cervical dystonia received either a single low dose of Daxxify (125U), a high dose of Daxxify (250U), or placebo. The primary endpoint of ASPEN-1, change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) at weeks 4 and 6, was met, with the high dose group showing a change of 12.7 points and the low dose group showing a change of 10.9 points. Secondary endpoints for improvement in Clinical Global Impression of Change (CGIC) and Patient Global Impression of Change (PGIC) at weeks 4 and 6 were also met. The median duration of effect was 20.3 weeks for the high dose group and 24.0 weeks for the low dose group. Common treatment-related adverse events were dysphagia, muscular weakness, and injection site pain.
In ASPEN-OLS, 357 adult participants (86 de novo) meeting diagnostic criteria for cervical dystonia received up to 4 sequential doses of 125U, 200U, 250U, or 300U of Daxxify for up to 88 weeks, with a total of 985 doses administered. Participants showed improvements in TWSTRS at weeks 4 and 6, with a median duration of 19.9 to 26.0 weeks. Common treatment-related adverse events were injection site pain, headache, and injection site erythema. Daxxify prescribing information includes a black box warning about the distant spread of toxin effect.
“DAXXIFY’s differentiated efficacy, duration and safety profile can help physicians deliver long-lasting symptom relief to patients suffering from cervical dystonia, while also helping payers address the total cost of care for this population,” said Mark J. Foley, Chief Executive Officer of Revance Therapeutics.
Cervical dystonia is a chronic movement disorder marked by repetitive rotation and/or bending of the neck due to uncontrollable muscle contractions, associated with pain and discomfort. First-line treatment for cervical dystonia typically employs neuromodulators, with Daxxify being the first and only peptide-formulated neuromodulator for the condition