Despite a pandemic delay and an FDA warning about quality control and record-keeping problems at a production site, Revance insisted it was optimistic the agency would approve its would-be Botox rival as recently as last week. Turns out the FDA had other plans.
Late Friday, the FDA turned away Revance’s application for its frown-line injection DaxibotulinumtoxinA thanks to “deficiencies” at the company’s manufacturing site, Revance said.
The company is “very disappointed by this unanticipated response,” and is “seeking further clarity,” CEO Mark Foley said in a statement.
Revance said it will request a meeting with the FDA to discuss the decision.
The FDA rejection came only days after the agency posted a redacted Form 483 discussing quality control and records issues its inspectors discovered at a manufacturing site during a July site visit. Revance quickly shot back, saying it had responded to the concerns and continued to expect an FDA approval this year.
After speaking with Revance’s management this weekend, Mizuho analyst Vamil Divan and his team said they’re expecting a 12- to 15-month delay for the drug, but “also believe Daxi is still approvable and will ultimately have an important role in the aesthetics and therapeutic toxin market.”
The company’s shares dropped by about 34% after hours on the news.
Meanwhile, aside from Revance’s regulatory efforts, the company is also battling a patent lawsuit from Botox maker AbbVie. A Revance spokesperson last week said it believes the patents at issue “are not infringed upon by Revance or our supply source partner Ajinomoto or are invalid.”
Revance was previously set for an FDA decision on the drug last November, but pandemic travel restrictions forced a regulatory delay.