By all accounts, Revance is preparing for the FDA’s approval and market launch of its lead compound daxibotulinumtoxinA for injection (DAXI). DAXI clinical trials looking at glabellar line treatment suggest the neuromodulator with its proprietary peptide technology is at least as good as Botox (onabotulinumtoxinA, Allergan) but lasts substantially longer.
On April 9, Revance announced former Allergan marketing professional Taryn Conway had joined the biotechnology company’s team “… as the company transitions from clinical-stage development to commercialization…,” according to a Revance press release.
The release of a new and different neuromodulator is big news given botulinum toxin type A procedures consistently rank first among the most popular minimally invasive treatments in the U.S. In 2018, plastic surgeons performed 7,437,378 botulinum toxin type A procedures. Since 2000, demand for botulinum type A procedures has soared 845%, according the 2018 National Plastic Surgery Statistics by the American Society of Plastic Surgeons (ASPS).
Shannon Humphrey, M.D., clinical assistant professor in dermatology and skin science, University of British Columbia, was principal investigator for a number of Revance DAXI studies and has had years of experience using the product in glabellar lines.
“This is a product that’s truly different,” Dr. Humphrey says. “In medicine we’re bombarded with me-too products that are differentiated based on price or a new label, but this really is a different product in a number of ways. One of the most important differentiators is that it creates a new category of injectable neuromodulator for glabellar lines that is longer in duration.”
DAXI Duration, Efficacy & Side Effects
DAXI’s median duration for treatment of moderate to severe frown lines was 24 weeks. That’s a good eight weeks longer than top competitors on the market, according to Dr. Humphrey.
“And if you actually look at the duration to the time to return to baseline to the original frown line, you’re looking at more like 27, 28 weeks,” she says.
Other trial results that are vital to the product’s market success include that it effectively treats frown lines and appears to be at least as safe as potential rival Botox.
“There’s a very high degree of efficacy — actually the highest response rate seen across studies of competitors. Over 95% at the four-week mark. So it’s not just in one study — across a very robust, large dataset, there’s a 95% response rate,” Dr. Humphrey says.
DAXI’s side effect profile is similar to other neuromodulators on the market, according to Dr. Humphrey.
“The side effects were mild, localized to the injection treatment area and transient,” she says. “From a confidence-in-science perspective, it works and it’s safe.”
The other interesting piece is around duration. “We see 24 weeks’ duration, for moderate-to-severe frown lines effectively treated and 28 weeks before patients go back to how their frown lines looked before.”
Researchers conducted one head-to-head study, the phase 2 BELMONT study, which had multiple treatment arms, including one with 20 units of onabotulinumtoxinA (Botox).
“That is approximately equivalent to the amount of daxibotulinumtoxinA 40 units, which is what Revance has decided to go ahead with for their filing,” Dr. Humphrey says. “Again, what we found in this study is that daxibotulinumtoxinA gets approximately eight weeks longer duration than that competitor.”
DAXI is a purified protein. The 150 kilodalton toxin is exactly the same as other neurotoxins on the market. But daxibotulinumtoxinA has a proprietary peptide.
“It’s a little amino acid chain that’s added to it, and through a number of basic science mechanisms, it leads to this longer duration,” Dr. Humphrey says. “We spend a lot of time talking about differentiation but as a foundation the active part of this drug is the same.”
Dr. Humphrey says dermatologists and others will learn more about how DAXI behaves compared to other neuromodulators once it has regulatory approval. She explains that in the clinical trial setting, researchers use it with a specific paradigm for injection and in a specific dose for all patients.
But there is something she says she noticed when treating patients with DAXI.
Dr. Humphrey is an investigator for and consultant to Revance. Drs. Chang and Fishman report no relevant disclosures.