FDA accepts Allergan’s application for neck line treatment

Published 30/06/2025, 13:38
FDA accepts Allergan’s application for neck line treatment

IRVINE, Calif. - The U.S. Food and Drug Administration has accepted for review Allergan Aesthetics’ supplemental premarket approval application for SKINVIVE by JUVEDERM to reduce neck lines, the AbbVie company (NYSE:ABBV) announced Monday. AbbVie, with its robust market capitalization of $322 billion and impressive gross profit margin of 71%, continues to demonstrate strong market presence. According to InvestingPro data, the company maintains a "GOOD" overall financial health score, suggesting solid operational stability.

If approved, SKINVIVE would become the first hyaluronic acid injectable treatment specifically targeting neck lines. The product is currently approved in the U.S. only for improving skin smoothness of the cheeks in adults over 21 years of age.

The application is supported by clinical study data that met all primary and secondary endpoints. According to investigator assessments, 80% of patients treated with SKINVIVE achieved at least a one-grade improvement in horizontal neck lines at one month post-treatment. Nearly 90% of treated patients reported improvement in neck appearance during the same period.

"The submission of SKINVIVE to treat neck lines demonstrates our continued focus on developing new indications for comprehensive lower face and neck treatment," said Darin Messina, senior vice president of aesthetics R&D at AbbVie.

Treatment-related adverse events were reported as mild in severity and consistent with the product’s known safety profile. Neck appearance ranks as a top concern among people seeking aesthetic treatments, with millions of consumers considering professional interventions for this area. With revenue growth of 5.45% in the last twelve months and 10 analysts recently revising earnings estimates upward, AbbVie appears well-positioned to capitalize on this market opportunity. For deeper insights into AbbVie’s growth potential and comprehensive analysis, explore the detailed Pro Research Report available on InvestingPro.

The FDA’s acceptance of the application represents a potential expansion of Allergan Aesthetics’ portfolio, which includes BOTOX Cosmetic and SkinMedica. Additional data from the clinical study will be presented at future medical conferences, according to the company’s press release statement. The company’s next earnings report is scheduled for July 25, 2025, which could provide further insights into the growth potential of its aesthetics division.

In other recent news, AbbVie announced its quarterly dividend of $1.64 per share, continuing its trend of regular financial operations. The dividend will be paid on August 15, 2025, to shareholders of record as of July 15, 2025. In clinical developments, AbbVie’s migraine prevention drug, atogepant, demonstrated superior results in a Phase 3 trial compared to topiramate, meeting its primary endpoint with fewer discontinuations due to adverse events. However, AbbVie’s venetoclax did not meet its primary endpoint in a Phase 3 trial for higher-risk myelodysplastic syndrome. Despite this, no new safety concerns were identified. In regulatory news, the FDA approved a label expansion for AbbVie’s MAVYRET, making it the first oral treatment for acute hepatitis C. This approval is expected to aid in treating more patients with HCV. Additionally, the Trump administration is considering new regulations that could impact pharmaceutical advertising, potentially affecting AbbVie and other companies.

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