Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), has announced that BOTOX® Cosmetic (onabotulinumtoxinA) is now available in China for the treatment of masseter muscle prominence (MMP). The masseter muscle, located in the lower face, is involved in chewing, and its prominence can create a wide or square-shaped lower face. The China National Medical Product Administration (NMPA) recently approved BOTOX® Cosmetic for the temporary reduction of noticeable to severe MMP in adults, making it the first neurotoxin in China approved for this condition. This approval brings with it the reliable dosing, extensive clinical backing, and physician training that accompany on-label treatments.
“Masseter prominence is a common aesthetic concern among my patients and the wider Asian population,” said Professor Sun Jiaming, the lead clinical investigator and Director of the Plastic Surgery Department at Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology. “There is a high demand for non-invasive treatments to improve the lower face shape. The approval of BOTOX® Cosmetic offers an effective option, administered in a single treatment every six months, that relaxes the masseter muscle, helping patients achieve a slimmer, more defined jawline.”
In a Phase 3 clinical trial, participants treated with BOTOX® Cosmetic showed an average facial width reduction of 5.2mm compared to those given a placebo. Results typically lasted between six to nine months. Improvement was also seen across all secondary measures, including patient-reported outcomes assessing the psychological impact, treatment expectations, and overall satisfaction. Participants receiving BOTOX® Cosmetic reported better ratings in social interactions, attractiveness, and confidence compared to those on placebo.
Adverse events were generally mild to moderate, consistent with the known effects of BOTOX® Cosmetic, which has maintained a solid safety profile for over 30 years. No new safety concerns were identified. The global clinical trial included multiple centers, with nearly 90% of participants identifying as Asian.
“BOTOX® Cosmetic for MMP is a significant focus in our global R&D pipeline,” said Carrie Strom, President of Global Allergan Aesthetics and Senior Vice President at AbbVie. “We are thrilled to launch 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 represents another milestone for the trusted global aesthetic brand. Beyond China, reducing MMP is an underutilized treatment for patients of all ages who desire a narrower lower face. Many individuals with noticeable MMP are unaware of potential treatments, and only a small percentage seek care. Additional regulatory applications for the use of onabotulinumtoxinA in treating MMP are planned globally. Currently, BOTOX® Cosmetic is not approved by the U.S. Food and Drug Administration for MMP.
