FDA Accepts Supplemental Biologics License Application for Botox Cosmetic for Masseter Muscle Prominence
Allergan Aesthetics announced the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of marked to very marked masseter muscle prominence (MMP) associated with masseter muscle activity in adults.
If approved, Botox Cosmetic would become the only neurotoxin with five aesthetic indications and the first and only approved for masseter muscle prominence in the U.S.
“This submission builds on the depth and versatility of Botox Cosmetic and reflects our continued investment in advancing aesthetic medicine,” said Darin Messina, Ph.D., senior vice president, head of aesthetics research and development, AbbVie, in the release. “At Allergan Aesthetics, our approach to innovation includes both developing new treatment options and continuing to expand the potential of established products. The pursuit of a fifth aesthetic indication demonstrates that commitment to addressing evolving patient needs.”
MMP can contribute to the appearance of a wider or more square lower face. This submission addresses a growing patient interest in non-surgical facial contouring options, offering a clinically studied approach to achieving improved jawline definition and shape, as well as a more slimming jawline overall. If approved, this indication would provide both patients and aesthetic specialists with a differentiated, science-backed treatment option.
“Patients are increasingly seeking overall facial assessments with non-surgical options to address aesthetic needs for the lower face,” supplied Steve Yoelin, MD, a coordinating clinical investigator with over 25 years of experience in minimally invasive medical aesthetics. “As facial assessment continues to evolve beyond individual treatment areas, this indication would further broaden the clinical utility of Botox Cosmetic, if approved, by providing an important new treatment option.”
Submission is supported by two Phase 3 studies (M21-416 and M21-417), demonstrating statistically significant improvements in masseter muscle prominence and patient satisfaction with treatment.
For important safety information and boxed warning, view the full release.
