FDA Sets PDUFA Date for Revance DAXI Neuromodulator

Revance Therapeutics

The United States Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for Revance Therapeutics’ DaxibotulinumtoxinA for Injection (DAXI) in the treatment of moderate to severe glabellar (frown) lines. In a press release issued by Revance, the company noted that, in its correspondence, the FDA stated that no potential filing review issues were identified and indicated in the BLA filing communication letter that it is not currently planning to hold an advisory committee meeting to discuss the application.

Revance Releases Phase 3 Study Results for Toxin RT002

Revance Announces Sakura 3 Data

Revance Therapeutics has released SAKURA Phase 3 study data for its injectable daxibotulinumtoxinA (RT002) for moderate-to-severe glabellar lines. The study included nearly 2,700 patients, who received up to three treatments and were followed for more than a year and a half. Based on investigator assessment, more than 95 percent of patients achieved a score of none or mild glabellar lines at maximum frown at week 4 after each of three treatments. The median time to return to baseline was 28 weeks. The median time to loss of none or mild wrinkle severity was 24 weeks.

Revance Appoints New President of Aesthetics and Therapeutics

Revances appoints new CCO of Aesthetics

Revance Therapeutics, a biotechnology company developing botulinum toxin products for aesthetic and therapeutic concerns has appointed Todd Zavodnick to chief commercial officer and president of its Aesthetics & Therapeutics division. Zavodnick will report to Revance’s CEO Dan Browne, and lead the company’s commercial operations along with the launch of its injectable daxibotulinumtoxinA (RT002).