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 expects to initiate its Phase 3 trials before the end of 2016. The program will include two placebo-controlled pivotal studies conducted at multiple sites in the U.S. and Canada, with the primary endpoint being a composite of the proportion of subjects who achieve a score of 0 or 1 (none or mild) and a two-point improvement from baseline in glabellar line severity on investigator assessment (IGS-FWS) and patient assessment (PFWS) scales, at maximum contraction (frown) at Week 4. The duration of the reduction of severity of the glabellar lines will be assessed as a secondary endpoint. The program will also include a long-term, open-label safety study. Revance plans to announce additional details on the study designs when the company begins dosing patients.
“We have been very pleased by the informative and productive discussions with the FDA and our ability to reach agreement on appropriate next steps for our pivotal frown line program,” said Dan Browne, president and CEO of Revance. “The design of our Phase 3 program is consistent with the FDA ‘Draft Guidance for Industry: Upper Facial Lines.’ We are finalizing the IND submission for the glabellar line program and have already begun study startup activities.”