Revance touts first therapeutic indication for Botox rival Daxxify

Revance Therapeutics secured an FDA approval on Monday for its Botox rival Daxxify in cervical dystonia, marking the drug’s first therapeutic indication.

Daxxify was approved last year as a long-lasting neuromodulator for the treatment of moderate to severe glabellar lines, better known as frown lines. The latest approval expands Daxxify’s reach to adults with cervical dystonia, a rare neurological condition in which the neck muscles involuntarily contract, causing abnormal movements and pain.

Dustin Sjuts

“This is a disease state where there hasn’t been anything new for quite some time and botulinum toxins are used quite frequently,” Revance president Dustin Sjuts told Endpoints News on Monday. “We’re excited for providers to have this peptide-formulated product in the market.”

The drug will be available in the coming weeks for a small number of providers as part of an early access program, and accessible more broadly in 2024, Revance execs said in an interview. They said they’d reveal more details on pricing in the future.

AbbVie’s Botox was first approved more than three decades ago for the treatment of eye muscle disorders and has since picked up a suite of indications across therapeutic and aesthetic settings, including cervical dystonia. Botox Cosmetic earned more than $1.6 billion in sales last year, while Botox Therapeutic raked in $2.25 billion.

Upon winning approval last September in the cosmetic setting, Revance touted Daxxify as a potentially longer-lasting alternative to other neuromodulators, with the potential for as few as two treatments per year. In June, the company launched a campaign urging neurotoxin users to “break up with Botox” in a 30-second song.

“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,” trial investigator Peter McAllister said in a news release.

Revance said Monday that the cervical dystonia approval opens the door to a $2.5 billion therapeutic neuromodulator market in the US. The company’s considering other therapeutic indications, including migraine and upper limb spasticity, where researchers recently completed a Phase II trial.

therapeutics
fda