With a product so anticipated that some mistakenly refer to it by the name of its company, Revance Therapeutics may soon have an identity issue.
The FDA has now approved Revance’s long-awaited Botox competitor, Daxxify (daxibotulinumtoxinA), and with that the company will have to find its branding footing.
Revance is not concerned, though. “People are gonna call it a wide range of things,” CEO Mark Foley said in an interview with Fierce Pharma. “Given that we’re still so early, we’ll be able to build the right brand name around the product.”
The cosmetic treatment temporarily removes moderate to severe glabellar (frown) lines. Like Botox, Daxxify is an injected neuromodulator. But Revance’s product is the first based on peptide exchange technology.
The key differentiator for Daxxify is its staying power. While Botox injections last for three months, Daxxify can sustain for six months and has worked for up to nine months in some patients. Daxxify’s duration benefits were established in phase 3 trials which included 2,700 patients and 4,200 treatments. The studies showed a single injection had a powerful effect on wrinkles.
“The most unmet need with toxins is duration,” Foley said. “We’ve got a fantastic label. We worked very closely with the agency to get the full 36 weeks of data into our label, which will allow us to support these marketing claims.”
Late-arriving Daxxify was first lined up for an FDA nod in November of 2020, but the pandemic got in the way, delaying inspection. When inspectors finally got a look at Revance’s production facility, they flagged quality control and record-keeping problems. Then, last October, the FDA slapped a complete response letter on Revance.
Revance worked through all five issues identified in the CRL, and the FDA signed off on the adjustments this July. At that time, however, the regulator identified three more concerns in a Form 483 citation. But the company had quick fixes for each.
“It’s been a long journey to get here,” Foley said. “We’re super excited because it will be the first time in over 30 years that a truly innovative neurotoxin has been brought to the market.”
The first, of course, was Allergan’s Botox, which hit the market in 1989. Between its cosmetic and therapeutic applications, Botox generated $4.7 billion in sales last year for AbbVie, which ponied up $63 billion to buy Allergan in 2019.
The company has yet to reveal a price for Daxxify for frown lines. As for its launch, the company will employ a preview strategy for two quarters.
“We want to get this in the hands of a small group of physicians that can use this product to understand how to get the best results,” Foley said. “We wanted to give that small group of injectors an opportunity to play with it before we went to the broad commercial launch.”
Revance also is investigating Daxxify for its therapeutic benefits. An FDA approval submission is planned in cervical dystonia. And a phase 2 study in upper lip spasticity has been completed.