Allergan Aesthetics, an AbbVie company, today announced that BOTOX Cosmetic (onabotulinumtoxinA) is now available for the treatment of masseter muscle prominence (MMP) in China. The masseter is one of the muscles in the lower face involved in chewing, and prominence of the masseter muscle can result in a wide and square lower face shape.
BOTOX Cosmetic was recently approved for the temporary improvement in the appearance of marked to very marked MMP in adults by the China National Medical Product Administration (NMPA). BOTOX Cosmetic is the first neurotoxin approved in China for MMP and offers the established dosing, robust clinical evidence and physician training that comes with on-label treatment.
“Masseter prominence is among the top aesthetics concerns for my patients and the broader Asian population, and there is a significant unmet need for minimally invasive treatment options for patients interested in addressing their lower face shape,” said Professor Sun Jiaming, lead clinical study investigator and Director of the Plastic Surgery Department of Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology. “The approval of BOTOX Cosmetic offers an effective option delivered in a single treatment dosed every six months that relaxes masseter muscles and help patients achieve a slimmer and more defined jawline.”
In a Phase 3 clinical trial, subjects treated with BOTOX Cosmetic had 5.2mm greater average reduction of facial width as compared to subjects treated with placebo. Results typically lasted 6-9 months following BOTOX Cosmetic treatment. Improvement was also seen in all secondary endpoints, as measured by multiple proprietary patient-reported outcome (PRO) instruments assessing psychosocial impact, treatment expectations and treatment satisfaction from the subject perspective. Subjects treated with BOTOX Cosmetic had improved ratings in psychosocial impact (satisfaction with level of interaction in social situations), attractiveness, and confidence compared to subjects treated with placebo.
Treatment-emergent adverse events for BOTOX Cosmetic were mild or moderate and consistent with known pharmacological effects of BOTOX Cosmetic, which has a well-established safety profile throughout its 30-year history. No new safety signals were observed. The clinical study was conducted in multiple centers globally and nearly 90 percent (87.3%) of subjects identified as Asian.
“BOTOX Cosmetic for masseter muscle prominence is a key focus for our global R&D pipeline,” said Carrie Strom, President, Global Allergan Aesthetics and Senior Vice President, AbbVie. “We are excited to be approved and launch first in China, one of our most important markets.”
With over 150 million vials of BOTOX and BOTOX Cosmetic distributed worldwide, the availability of BOTOX Cosmetic for MMP in China marks another important milestone for the global aesthetic brand that medical providers and patients know and trust. Beyond China, reduction of MMP is a highly desirable, yet undertreated, indication for patients across all age ranges worldwide who may prefer a narrower lower face shape. Those bothered by marked or very marked MMP are typically unaware of potential treatment options and very few receive treatment. Additional regulatory applications for onabotulinumtoxinA treatment for MMP are planned globally. BOTOX Cosmetic is currently not approved by the U.S. Food and Drug Administration for MMP.
