Botulinum Toxin Daxxify Gets FDA Nod for Cervical Dystonia

Megan Brooks

August 15, 2023

The US Food and Drug Administration (FDA) has expanded the indiction for daxibotulinumtoxinA-lanm injection (Daxxify, Revance Therapeutics) for the treatment of cervical dystonia in adults, the company has announced.

It's the first therapeutic indication for Daxxify, a peptide-formulated neuromodulator approved last year for the temporary improvement in the appearance of glabellar (frown) lines in adults, as reported by Medscape Medical News.

It's estimated that about 60,000 people in the US have cervical dystonia, a chronic, debilitating disease characterized by involuntary contraction of neck muscles that causes abnormal movements, pain, and awkward posture of the head and neck. Neuromodulators are considered the first line of treatment for the condition.

The FDA granted orphan drug designation to Daxxify for the treatment of cervical dystonia in adults in 2017.

The agency approved the drug for this indication on the basis of data from the phase 3 ASPEN clinical program, which included 382 patients with moderate to severe cervical dystonia.

In the ASPEN-1 study, Daxxify was "effective, generally safe, and well tolerated" across both dose groups (125U and 250U). The median duration of effect was 24 and 20.3 weeks, respectively, the company says in a news release announcing the approval.

Joseph Jankovic, MD, professor of neurology and director of the Parkinson's Disease Center and Movement Disorders Clinic at Baylor College of Medicine in Houston, presented the ASPEN-1 results at the 2021 International Congress of Parkinson's Disease and Movement Disorders.

In his presentation, Jankovic noted that side effects "were remarkably minimal," and he called attention to the low frequency of neck weakness or dysphagia in comparison with results seen in other studies of botulinum toxin for patients with cervical dystonia. The rates of dysphagia were 1.6% and 3.9% in the 125U and 250U treatment groups, respectively.

In the ASPEN OLS study, symptoms continued to improve with successive treatments at doses up to 300U, while adverse events remained low.

The company expects Daxxify to be available in early 2024.

Daxxify joins a crowded space. AbbVie’s Botox (onabotulinumtoxinA), Galderma's Dysport (abobotulinumtoxina), Merz Pharmaceuticals' Xeomin (incobotulinumtoxinA), and US WorldMeds' Myobloc (rimabotulinumtoxinb) have already been approved in the US for treatment of cervical dystonia.

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