BOTOX® Cosmetic Approved in China for Masseter Muscle Prominence
Key Insights
Allergan Aesthetics (search)' BOTOX® Cosmetic (search) (onabotulinumtoxinA) is now available in China for treating masseter muscle prominence (search) (MMP) in adults.
The approval marks BOTOX® Cosmetic (search) as the first neurotoxin approved in China for MMP, a significant aesthetic concern in the region.
Clinical trials demonstrated BOTOX® Cosmetic (search)'s effectiveness in reducing facial width by an average of 5.2mm compared to placebo, with effects lasting 6-9 months.
Allergan Aesthetics (search), an AbbVie (search) company, has announced the availability of BOTOX® Cosmetic (search) (onabotulinumtoxinA) in China for the treatment of masseter muscle prominence (search) (MMP) in adults. This approval by the China National Medical Product Administration (NMPA) marks a significant advancement in addressing aesthetic concerns related to lower face shape in the Asian population.
MMP is characterized by the enlargement of the masseter muscle, leading to a wider, more square-shaped lower face. This condition can stem from heredity or overuse of the muscle through activities like chewing gum, clenching, or bruxism. While primarily a cosmetic concern, MMP can impact self-perception and cause psychological distress.
Clinical Trial Results
The approval of BOTOX® Cosmetic (search) was supported by robust clinical trial data. A Phase 3 clinical trial demonstrated that subjects treated with BOTOX® Cosmetic experienced a 5.2mm greater average reduction in facial width compared to those treated with placebo. The effects of the treatment typically lasted between 6 to 9 months. Furthermore, the trial assessed secondary endpoints using patient-reported outcome (PRO) instruments, revealing improvements in psychosocial impact, attractiveness, and confidence among subjects treated with BOTOX® Cosmetic.
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, noted, "The approval of BOTOX® Cosmetic (search) 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."
Safety Profile
The safety profile of BOTOX® Cosmetic (search) in the clinical trial was consistent with its established history. Treatment-emergent adverse events were reported as mild or moderate, aligning with the known pharmacological effects of the drug. No new safety signals were identified during the study, which was conducted across multiple centers globally, with approximately 90% of subjects identifying as Asian.
Future Development
Carrie Strom, President, Global Allergan Aesthetics (search) and Senior Vice President, AbbVie (search), stated, "BOTOX® Cosmetic (search) for masseter muscle prominence (search) is a key focus for our global R&D pipeline. We are excited to be approved and launch first in China, one of our most important markets." Allergan Aesthetics intends to pursue further regulatory applications for onabotulinumtoxinA treatment for MMP in additional global markets. Currently, BOTOX® Cosmetic is not approved by the U.S. Food and Drug Administration for MMP.
With over 150 million vials of BOTOX® and BOTOX® Cosmetic (search) distributed worldwide, the availability of BOTOX® Cosmetic for MMP in China represents a significant milestone for the brand. The company aims to address the unmet need for minimally invasive treatment options for individuals seeking to improve the appearance of their lower face shape.