With trial win, AbbVie cues up Botox for another cosmetic indication

18 Sep 2023
www.fiercepharma.com
Clinical ResultPhase 3AcquisitionDrug Approval
With trial win, AbbVie cues up Botox for another cosmetic indication
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Source: FiercePharma
AbbVie plans to submit an application for approval of Botox to treat platysma prominence, a cosmetic condition related to aging that causes muscle protrusions in the neck, jawline and the lower part of the face.
With the loss of elasticity in the skin that accompanies aging, platysma bands can become more apparent, protruding from the neck. While it’s not a medical issue, some people may wish to diminish their appearance for cosmetic reasons.
Now, they soon may have a familiar treatment for the condition—AbbVie’s Botox (onabotulinumtoxinA). Already approved as an injection to reduce wrinkles in the forehead and around the eyes—as well as a wide variety of other medical disorders—Botox is in position to expand its cosmetic uses to the moderate to severe form of platysma prominence.
Monday, AbbVie revealed positive results of a second phase 3 trial of Botox for the indication, which can also include disruption of the jawline and the lower part of the face, which is attributed to contraction of the platysma muscle.
In a trial that included 426 participants, those given Botox experienced a significant resolution of the protrusions versus those on placebo based on investigator and patient assessment for the appearance of platysma prominence.
All secondary endpoints were met, as measured by patient satisfaction on appearance, psychosocial impact and treatment expectations.
No new safety signals were observed. Results from the M21-310 trial matched up to those from a previous study, M21-309, which were revealed in April of this year.
AbbVie expects to apply for approval from the FDA by the end of this year.
If approved, Botox would become the first and only neurotoxin for the condition, AbbVie said. Current treatment options include surgical approaches such as lower rhytidectomy (neck lift) and platysmaplasty.
In 2022, AbbVie reported cosmetic sales of BotoxBotox reached $2.6 billion, while its therapeutic uses accounted for $2.7 billion in sales. Medical disorders BotoxBotox treats include migraine, limb spasticity and bladder conditions.
The company is bracing for competition in the cosmetic space from Revance’s Daxxify, which was approved last year and generated $22 million in sales the second quarter of this year.
AbbVie gained Botox with its $63 billion acquisition of Allergan in 2019.
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