Revance, a prominent player in the aesthetics market, has now made a strategic move into the promising therapeutic arena. Following its successful debut with Daxxify for temporary improvement of glabellar lines, the company has secured FDA approval for a new indication – treating cervical dystonia in adults. This recent regulatory green light signifies Daxxify’s expansion into therapeutic applications.
Cervical dystonia is a condition characterized by involuntary contractions of neck muscles, leading to abnormal movements, discomfort, and awkward head and neck posture. Daxxify, like its well-known counterpart Botox, falls within the category of neuromodulators and is considered the primary treatment option for this condition, which impacts approximately 60,000 individuals in the US.
However, the challenge with current treatments is that symptoms tend to resurface in about eight to 10 weeks after a treatment cycle, which is typically administered every 12 weeks. Recognizing this unmet need, Revance has positioned Daxxify as a potential solution, aiming to extend the duration of effect to a substantial 12 weeks or more. According to Dustin Sjuts, President of Revance, this extended effect could offer patients an additional three to five weeks without requiring further treatment, significantly enhancing their experience.
The foray into the therapeutic space also presents considerable revenue potential for Daxxify. Revance estimates the total US market opportunity for therapeutic neuromodulators to be $2.5 billion, with cervical dystonia treatment accounting for $345 million of this potential.
“We are very pleased to see the expansion of the Daxxify label to include our first therapeutic indication, unlocking a new market opportunity for Daxxify following the product’s recent launch in the aesthetics market. Further, we believe FDA approval represents a significant advancement in the treatment of cervical dystonia. Daxxify’s differentiated efficacy, duration and safety profile can help physicians deliver long-lasting symptom relief to patients suffering from cervical dystonia, while also helping payers address the total cost of care for this population. We look forward to conducting our early experience and education program, PrevU, which will involve a small group of thought leaders, followed by a progressive commercial rollout beginning in 2024. Today’s approval is an important milestone for Revance, marking the start to our therapeutics franchise.”
– Chief Executive Officer Mark J. Foley
Daxxify’s approval for cervical dystonia is backed by data from Phase III trials, ASPEN 1 and ASPEN OLS. The trials demonstrated the safety and efficacy of Daxxify at two distinct doses, with the respective groups experiencing median durations of effect of 24 and 20.3 weeks.
In terms of its initial foray into aesthetics with frown lines, Daxxify has achieved impressive success, generating $49 million in revenue to date, according to CEO Mark Foley. This strong performance sets a promising precedent for Daxxify’s expanded role in the therapeutic landscape.
