Revance Therapeutics

Revance DAXI Takes Next Step Toward FDA Approval

Revance Files BLA for DAXI

Revance Therapeutics has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for DaxibotulinumtoxinA for Injection (DAXI) in the treatment of moderate to severe glabellar (frown) lines. The submission includes results from the three SAKURA Phase 3 trials in which DAXI demonstrated that half of the patients treated maintained none or only mild frown lines for at least 24 weeks (approximately six months) after a single treatment.

Revance Botulinum Toxin Achieves Six-Month Duration in Phase 3 Trials

Revance releases phase 3 clinical data

Revance Therapeutics’ DaxibotulinumtoxinA for Injection (RT002) achieved six-month duration in two pivotal SAKURA Phase 3 clinical studies for the treatment of glabellar lines. RT002 met its primary composite endpoint by delivering highly statistically significant improvement against placebo in reducing the severity of glabellar lines in both SAKURA 1 and SAKURA 2.

Revance Therapeutics Begins RT002 Studies

Revance Therapeutics commenced a pair of double-blind, placebo-controlled, North American Phase 3 trials to evaluate single injections of drug candidate DaxibotulinumtoxinA (RT002) for the treatment of glabellar lines in about 600 total patients. The trials follow the successful BELMONT study that showed RT002 delivered six-month duration of effect, with no ptosis at the 40-unit level, in treating frown lines.

Revance to Commence Phase 3 Toxin Trials

Biotechnology company Revance Therapeutics has announced the completion of its Type B/pre-IND/pre-Phase 3 meeting with the U.S. Food and Drug Administration (FDA) regarding injectable DaxibotulinumtoxinA (RT002) for glabellar lines. The company will be moving forward with an Investigational New Drug (IND) submission for a Phase 3 clinical program for RT002 in glabellar lines as well as other supportive studies required for Biologics License Application (BLA) filing.

Revance Appoints New SVP

Roman G. Rubio, MD, has joined Revance Therapeutics as the biotechnology company’s senior vice president of clinical development. Dr. Rubio will lead Revance’s clinical development team, focusing on further advancing its neurotoxin development programs.Prior to Revance, Dr. Rubio was senior vice president of translational medicine at Avalanche Biotechnologies, and he served more than 11 years at Genentech.

Revance Reports Positive RT002 Results

Revance Reports Positive RT002 Results

Revance Therapeutics has announced positive 24-week results from its multicenter BELMONT Phase 2 active comparator study of injectable RT002 for the treatment of glabellar lines. RT002 is an injectable botulinum toxin type A investigational drug. The ongoing study has enrolled 268 subjects to compare the safety, efficacy and duration of effect of three doses of RT002 against placebo and current market leader, Botox Cosmetic (Allergan).