The FDA accepted for review a supplemental Biologics License Application for AbbVie's Botox Cosmetic to treat masseter muscle prominence, a jaw-muscle bulge that can widen the face. If approved, Botox Cosmetic would become the first and only neurotoxin cleared for that use in the US and the fifth aesthetic indication for the drug. The filing is supported by two Phase 3 studies that met their primary endpoints with statistically significant improvements versus placebo. AbbVie's broader business reported net revenue of just under $17 billion in the latest quarter, up more than 10% year over year, driven by immunology and neuroscience growth.
AbbVie IncFDA accepted Botox Cosmetic application for masseter muscle prominence, a new indication with Phase 3 success.
