After delays and setbacks, Revance Therapeutics has a new date with the FDA for its potential rival to AbbVie's Botox.
Revance's DaxibotulinumtoxinA is a long-acting candidate under review to treat frown lines. Friday, the FDA accepted the company's latest submission and granted a six-month review period, setting up a decision by Sept. 8.
The FDA's new review will require a reinspection of the company's manufacturing facility. In October, the FDA rejected the company's previous application because of “deficiencies” at DaxibotulinumtoxinA’s manufacturing site.
While the FDA's inspection write-up was heavily redacted, Revance has previously identified its supply source partner as Ajinomoto, a Japanese food and biotechnology company.
After the October rejection, market watchers held out hope for the treatment. After speaking with Revance management, Mizuho analyst Vamil Divan wrote to clients at the time that the drug was “still approvable" and would "ultimately have an important role in the aesthetics and therapeutic toxin market."
Aside from the manufacturing setback, the company has also faced a legal challenge. In October, AbbVie subsidiary Allergan sued Revance for alleged patent infringement. Revance, for its part, said the lawsuit was part of a strategy to "distract" potential Botox rivals.
Aside from frown lines, Revance is assessing its med's use for upper limb spasticity.