Allergan Aesthetics’ SKINVIVE by JUVÉDERM Accepted for FDA Review to Reduce Neck Lines

Allergan Aesthetics, an AbbVie (NYSE: ABBV) company, announced that the supplemental premarket approval (sPMA) application for its SKINVIVE by JUVÉDERM has been accepted for review by the US Food and Drug Administration (FDA). Originally approved by the FDA for improving cheek smoothness in adults aged 21 and older, the product is now under review for its use in reducing neck lines to enhance neck appearance.

Clinical Study Results
The application is supported by results from a multicenter, evaluator-blinded, randomized controlled study. The study achieved all primary and secondary endpoints, demonstrating the product’s efficacy and safety. In the trial, 80% of patients treated with SKINVIVE by JUVÉDERM achieved at least a 1-grade improvement at month 1. Additionally, nearly 90% of patients reported an improvement in their neck appearance at month 1. The product also exhibited a favorable safety profile.-Fineline Info & Tech