AbbVie says latest FDA approval expands Botox use beyond face
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The U.S. Food and Drug Administration (FDA) has approved the fourth indication for AbbVie’s (NYSE:ABBV) anti-wrinkle therapy Botox Cosmetic, expanding its use beyond the face for the first time, the company announced late Friday.
With the latest approval, the injectable will be allowed for use in adults to temporarily improve the appearance of moderate to severe vertical bands, also known as platysma bands, between the jaw and neck.
AbbVie (NYSE:ABBV) said Botox Cosmetic, added with its $63B acquisition of Allergan in 2020, is the first and only product approved for four aesthetic indications, namely, forehead lines, frown lines, crow’s feet lines, and now platysma bands.
The company added that the muscle relaxer is also the first product of its kind to expand beyond the face. The approval is backed by data from Phase 3 trials in which Botox Cosmetic led to a statistically significant improvement in the appearance of platysma bands compared to placebo.