One year and another FDA inspection later, Revance has been hit with a second round of manufacturing citations, adding another wrinkle to its approval bid for a potential Botox rival.
After an FDA visit last summer yielded a Form 483, the FDA completed its re-inspection of Revance’s production facility in July, the company said in a recent investor report. The good news is the FDA closed out the original five observations it made in 2021. The bad news? The FDA slapped Revance with another Form 483, this time outlining three separate issues.
Revance says it has “already provided its responses” and feels “confident” about the adjustments it’s proposed.
Still, the FDA rebuke bodes ill for the near-term approval DaxibotulinumtoxinA—Revance’s would-be rival to AbbVie’s Botox—which is up for a potential U.S. green light by Sept. 8.
In the latest Form 483, the FDA’s first observation covers failures to consistently respond to deviations of standard operating procedures. The second centers on the company's operation and cleaning of filtration equipment. In the third observation, the FDA said Revance failed to include a redundant site for working cell bank storage in its application.
Revance’s regulatory path for DaxibotulinumtoxinA has been riddled with potholes. Before the company earned its first Form 483 last year, COVID-19 restrictions delayed a 2020 inspection of the company’s Newark, California plant, forcing Revance to wait on an approval decision.
Things came to a head last July, however, when the FDA handed down five observations regarding quality control measures and record-keeping.
In October 2021, Revance said it had responded to the issues and still expected an FDA approval by the end of 2021.
Aside from Revance's regulatory ordeals, the company is battling a patent lawsuit from Botox maker AbbVie. A Revance spokesperson last year said it believes the patents at issue "are not infringed upon by Revance or our supply source partner Ajinomoto or are invalid."
The FDA is weighing DaxibotulinumtoxinA for approval as an injection for frown lines, which is one of Botox’s approved aesthetic uses.
Last year, AbbVie’s Botox generated $2.2 billion in its aesthetic uses.