U.S. FDA Approves First Therapeutic Indication for Revance’s DAXXIFY® (DaxibotulinumtoxinA-lanm) for Injection for the Treatment of Cervical Dystonia
Retrieved on:
Monday, August 14, 2023
FDA, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Neurotoxin, Therapy, Dysphagia, New England Institute of Religious Research, Muscular system, Speech, OLS, Head, Hubli railway division, Headache, Trial of the century, Pain, Spasmodic torticollis, Physician, Patient, The Retreat, Torticollis, ASPEN, Recurrence, Death, Spasticity, Acetylcholine, Pharmaceutical industry
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.”
Key Points:
- 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.