The FDA has accepted a supplemental Biologics License Application (sBLA) for Botox Cosmetic to treat masseter muscle prominence, advancing AbbVie's effort to expand the toxin's approved indications beyond the current glabellar, forehead, and crow's feet labels.
Regulatory
FDA Accepts sBLA for Botox in Masseter Prominence
AbbVie advances jawline indication; regulatory path clears for new patient population.
1-YEAR MOVE
ABBV
▲11.6%
| Ticker | Company | 1-year change |
|---|---|---|
| ABBV | AbbVie (Allergan Aesthetics) | +11.6% |
Masseter Botox approval could unlock premium-priced jawline market for practices.
Masseter treatment is already performed off-label by many practices, but FDA approval would formalize the indication, enable manufacturer-backed training and marketing, and likely drive patient demand through direct-to-consumer channels. For practice owners, this represents a revenue opportunity—masseter Botox commands premium pricing (often $15–25 per unit vs. $12–18 for standard facial units) and appeals to patients seeking jawline definition without surgery. Approval timing remains uncertain, but the sBLA acceptance suggests a 2026–2027 launch window is plausible.
Source: original report ↗
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