This innovative therapy, the first and only peptide-formulated, long-lasting neurotoxin of its kind, presents a compelling option for patients and physicians grappling with the challenges of this painful and debilitating condition. The launch represents Revance's entry into the vast and expanding U.S. therapeutic neurotoxin market.

"DAXXIFY provides a significant opportunity for Revance and marks the culmination of our decades-long mission to bring true innovation to the therapeutics market. Between DAXXIFY’s differentiated clinical profile, compelling value proposition and safety profile, DAXXIFY has the potential to address the unmet needs of all stakeholders, including patients, physicians, and payers," said President and Chief Executive Officer, Mark J. Foley.

Following the FDA's approval of DAXXIFY for cervical dystonia in August 2023, Revance initiated the DAXXIFY cervical dystonia PrevU early experience program. This program was designed to optimize treatment outcomes for patients and facilitate seamless integration into clinical practice. Subsequently, Revance established a robust commercial infrastructure in anticipation of the launch, securing a permanent J-Code for DAXXIFY from the U.S. Centers for Medicare & Medicaid Services (CMS) to streamline reimbursement pathways for providers. Additionally, reimbursement support services were operationalized to mitigate potential adoption barriers, while patient affordability programs were introduced to assist individuals with out-of-pocket expenses.

"One of our primary goals has been to minimize barriers and ensure access to DAXXIFY for the large number of CD patients who have early symptom re-emergence and are not adequately controlled on current toxin treatments," commented David. A. Hollander, M.D., MBA, Chief Medical Officer and Global Therapeutics Franchise Lead.

Dr. Peter McAllister, co-founder, and medical director of the New England Institute for Neurology and Headache, emphasized the transformative potential of DAXXIFY based on his experiences as an investigator in the ASPEN program and a participating physician in PrevU. "Many patients struggle with pain and discomfort between injections with current treatment options, but with DAXXIFY, my patients have experienced long-lasting symptom relief. Further, DAXXIFY’s safety profile continues to be encouraging over a broad range of doses. As patients can currently only access treatment every 12 weeks based on product labeling and reimbursement guidelines, I’m excited to offer my patients a new therapy that offers sustained symptom control."

With DAXXIFY's introduction, Revance is poised to redefine the standard of care for cervical dystonia, offering patients renewed hope and clinicians a powerful tool to combat this challenging condition.