U.S. Food and Drug Administration Accepts for Review Allergan Aesthetics Premarket Approval Application for SKINVIVE by JUVÉDERM® for the Improvement of Neck Appearance

Core Viewpoint - Allergan Aesthetics, a subsidiary of AbbVie, has submitted a supplemental premarket approval application for SKINVIVE by JUVÉDERM® to reduce neck lines, which is currently approved for improving cheek skin smoothness in adults over 21 [1][7]. Group 1: Product Development and Market Potential - SKINVIVE by JUVÉDERM® is an injectable hyaluronic acid product aimed at improving neck appearance, addressing a significant concern for many consumers seeking aesthetic treatments [2][4]. - The product could become the first hyaluronic acid injectable specifically targeting neck lines, expanding Allergan's portfolio which includes BOTOX Cosmetic® and SkinMedica® [2][7]. - The submission is backed by a clinical study showing that 80% of patients achieved at least a 1-grade improvement in neck lines after one month of treatment [3]. Group 2: Clinical Study Results - The clinical study met all primary and secondary endpoints, with nearly 90% of patients reporting improvement in neck appearance as assessed by the Global Aesthetic Improvement Scale [3]. - Patients reported being significantly less bothered by their neck appearance post-treatment, while the control group showed no significant change [3]. - Adverse events associated with SKINVIVE by JUVÉDERM® were mild and consistent with its known safety profile, indicating a favorable safety outcome for the product [3]. Group 3: Company Background and Strategy - Allergan Aesthetics focuses on developing innovative aesthetic solutions, with a commitment to addressing consumer needs in the aesthetics market [36]. - AbbVie aims to deliver innovative medicines and solutions across various therapeutic areas, including aesthetics, highlighting its strategic focus on addressing health issues and enhancing quality of life [37].