The FDA injected a Form 483 frown into Revance Therapeutics’ plans to gain regulatory approval for its Botox rival daxibotulinumtoxinA, citing quality control and records issues at the manufacturing site.
After a July inspection, the regulatory rebuke outlined five areas in which the company needed to make improvements, specifically regarding quality control measures and record-keeping.
Revance said it responded to the issues this summer and continues to expect FDA approval by the end of the year. Although the manufacturing site was redacted in the Form 483, Revance has previously identified its supply source partner as Ajinomoto, a Japanese food and biotechnology company.
The FDA has daxibotulinumtoxinA under consideration for approval as an injection for frown lines, which is one of Botox’s approved aesthetic uses. A decision for the agency was originally slated for November 2020, but travel restrictions imposed during the pandemic delayed a preapproval inspection of the facility until July.
The Form 483 follows news that earlier this month AbbVie filed an infringement suit against Revance on five Botox patents. The suit is an attempt to freeze Revance from launching the product. AbbVie claims its patents will be infringed and seeks damages that could include a “reasonable royalty and lost profits.”
After speaking with a patent consultant, analysts with Wells Fargo said the legal action is "very unlikely to derail" Revance's potential launch. For one, the suit could to take up to three years to wind its way through the courts, the analysts said.