After debuting in the aesthetics market with Daxxify last year, Revance has made its way to the potentially lucrative therapeutic space.
With a Monday FDA nod to treat cervical dystonia in adults, Daxxify has snagged its first therapeutic indication. The green light comes a little less than a year after the injection’s initial approval for temporary improvement of glabellar lines, or frown lines.
In patients with cervical dystonia, the neck muscles contract involuntarily, causing abnormal movements, pain and awkward posture of the head and neck, Revance explained in a press release. Neuromodulators like Daxxify—and its rival Botox—are considered the first-line of treatment for the condition, which affects roughly 60,000 people in the U.S.
The problem is, with current treatment—administered every 12 weeks—some 88% of cervical dystonia patients see their symptoms come back after around eight to 10 weeks.
Aside from a duration of effect that spans at least 12 weeks, Revance figures its product could allow patients to go another three to five weeks without needing to re-up on treatment, Revance’s president, Dustin Sjuts, said in an interview.
That would be “pretty meaningful” to patients, the executive commented.
Entry into the therapeutic arena also holds high sales promise for Daxxify. The total U.S. therapeutic neuromodulator market opportunity for Daxxify is $2.5 billion, including $345 million in cervical dystonia specifically, Revance said.
As for the drug’s next therapeutic frontier, “the other big category … is migraine,” Revance’s CEO Mark Foley said during the interview. The company is now working with leaders in the field to understand a potential clinical pathway in migraine, he explained.
As for launch plans in cervical dystonia, Revance will take the same route it did in aesthetics, first by getting Daxxify into the hands of a thought leader “faculty,” Sjuts said.
Those opinion leaders will take initial cervical dystonia patients through a nonclinical program that’ll garner insights in terms of treatment intervals and doses that will “help inform the launch as we go into 2024,” Sjuts said.
The goal is to “inform [the KOLs] with real-world insights and let that help drive the introduction into the broader market,” he added.
In cervical dystonia, Daxxify won approval based on data from the phase 3 trials ASPEN 1 and ASPEN OLS. In those studies, Daxxify was found safe and effective at two separate doses with a median duration of effect of 24 and 20.3 weeks for the respective groups.
So far, during the drug's initial launch in frown lines, Daxxify has generated $49 million, Foley said.