Revance Therapeutics has entered the cervical dystonia treatment arena after the US Food and Drug Administration (FDA) approved Daxxify (daxibotulinumtoxinA-lanm) for the neck condition, which is characterised by involuntary muscle contractions.

Botulinum toxins are considered the first line of treatment for cervical dystonia and work by blocking nerve and muscle signalling pathways. Already approved for use in the treatment space are AbbVie’s Botox (onabotulinumtoxinA), Galderma’s Dysport (abobotulinumtoxina), Merz Pharmaceuticals’ Xeomin (incobotulinumtoxinA), and US WorldMeds’ Myobloc (rimabotulinumtoxinb).

As per Revance, Daxxify should be available at the beginning of 2024.

Daxxify is a peptide-formulated neuromodulator that was previously approved for aesthetic use in the improvement of glabellar (frown) lines. The popularity of AbbVie’s Botox has meant the drug’s name has effectively become synonymous with the treatment for wrinkles and has enjoyed market domination for a few decades. Still, Revance says Daxxify has an advantage over other alternatives since it is longer lasting.

With Daxxify’s label expansion by the FDA, the company will now renew its rivalry with AbbVie in cervical dystonia treatment. Revance says the therapeutic neuromodulator market opportunity for Daxxify is $2.5bn – of which $345m is contributed by the cervical dystonia market.

The FDA based its approval on data from the ASPEN clinical programme which demonstrated that Daxxify improved symptoms with a median duration of 24 weeks at 125U dosing.

ASPEN investigator and co-founder and the New England Institute for Neurology and Headache medical director Dr Peter McAllister said: “Currently, patients experience painful and life-limiting symptom recurrence as early as eight to ten 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.”