The U.S. Food and Drug Administration (FDA) recently approved a fourth indication for AbbVie Inc.'s (ABBV, Financial) Botox Cosmetic. This marks the first time the anti-wrinkle treatment has been extended for use beyond the face. The new approval allows adults to temporarily improve the appearance of moderate to severe vertical bands (platysma bands) between the jawline and neck.
Botox Cosmetic is the first and only product to receive four cosmetic indications. It was previously approved for improving forehead lines, frown lines, and crow's feet. AbbVie expanded its aesthetic portfolio significantly when it acquired Allergan for $63 billion in 2020.
The approval of the new indication is based on data from Phase 3 clinical trials, which showed that Botox Cosmetic significantly improved the appearance of platysma bands compared to a placebo. This makes it the first product of its kind to be approved for areas beyond the face.
