U.S. FDA Approves First Therapeutic Indication for Revance’s DAXXIFY® (DaxibotulinumtoxinA-lanm) for Injection for the Treatment of Cervical Dystonia
Peter McAllister, M.D., ASPEN investigator and co-founder and medical director of the New England Institute for Neurology and Headache, commented: “As an ASPEN investigator, I am excited to see the approval of a new treatment option to address symptom reemergence prior to retreatment, a common issue for cervical dystonia patients. Currently, patients experience painful and life-limiting symptom recurrence as early as eight to 10 weeks in clinical practice but cannot be re-treated until 12 weeks. DAXXIFY® is the first long-acting neuromodulator that has the potential to address this significant unmet need -- demonstrating durable symptom relief between treatment cycles and providing the opportunity to extend treatment intervals.”
- In 2017, the U.S. FDA granted orphan drug designation to DAXXIFY® for the treatment of cervical dystonia in adults.
- Further, we believe FDA approval represents a significant advancement in the treatment of cervical dystonia,” said Chief Executive Officer Mark J. Foley.
- “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.
- DAXXIFY® is not approved for the treatment of spasticity or any conditions other than cervical dystonia and glabellar lines.