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The FDA Accepted Revance Therapeutics' Application for Approval Of Its Botox Competitor

By Todd Campbell - Feb 6, 2020 at 3:09PM

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The company's frown line treatment moved closer to commercialization today.

A new alternative to Allergan's (AGN) blockbuster aesthetics treatment Botox may be available by the end of 2020. On Thursday, Revance Therapeutics (RVNC 0.99%) announced the Food and Drug Administration (FDA) accepted its application for approval of DAXI (daxibotulinumtoxinA for injection), a long-lasting neurotoxin for use in treating frown lines.

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A clinical-stage biotech, Revance Therapeutics recently in-licensed U.S. marketing rights to TEOXANE SA's hyaluronic acid dermal fillers, which are used in aesthetic procedures. That accelerated the company's transition to a commercial-stage company, giving it an opportunity for revenue while it awaits an FDA go/no-go decision on DAXI. The company filed its application for DAXI's approval late last year.

The FDA is reviewing DAXI under its standard 10-month timeline, and DAXI's prescription drug user fee act (PDUFA) decision date has been set for Nov. 25, 2020. Regulators don't currently expect to convene an advisory committee meeting to debate DAXI's merits, a move that may suggest an easier pathway to an FDA green light.

If regulators cooperate, Revance Therapeutics plans to position DAXI as a longer-lasting alternative to Botox. In phase 3 clinical trials, DAXI helped reduce frown lines for a median 24 weeks. By comparison, Botox Cosmetic's efficacy lasts between three to four months.

Trials evaluating DAXI as a treatment for crow's feet and forehead lines are ongoing, with data expected by mid-year. Revance Therapeutics estimates the total facial aesthetics market is worth $2.2 billion annually.


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