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FDA approves new use for Allergan's dermal filler

Published 03/05/2024, 09:58 PM
© Reuters.
ABBV
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IRVINE, Calif. - Allergan (NYSE:AGN) Aesthetics, an AbbVie company (NYSE: NYSE:ABBV), has received U.S. FDA approval for its JUVÉDERM® VOLUMA® XC product to be used in the temple region to treat moderate to severe temple hollowing in adults over 21. This marks the first FDA-approved hyaluronic acid dermal filler for this specific facial area, with results lasting up to 13 months post-optimal treatment.

The clinical study supporting the approval demonstrated significant patient satisfaction, with over 80% of participants noting at least a one-point improvement in temple hollowing at the three-month mark, and satisfaction levels remaining high for over a year. Subjects in the trial also reported looking, on average, five years younger six months following treatment.

Carrie Strom, President of Allergan Aesthetics, highlighted the approval as evidence of the company's commitment to innovation and patient care. The treatment is designed to add volume to the temple area, creating a more balanced facial appearance.

Dr. Deirdre Hooper, a board-certified dermatologist and clinical trial investigator, expressed enthusiasm for the upcoming training of injectors on using JUVÉDERM® VOLUMA® XC, which is expected to be available towards the end of the year after healthcare providers complete a mandatory training program.

The safety and effectiveness of JUVÉDERM® VOLUMA® XC were evaluated in a randomized, controlled, multicenter clinical study. Side effects, such as tenderness and swelling, were mostly mild or moderate and resolved within two to four weeks. The product is also approved for injection in the cheek area to correct age-related volume loss and in the chin region to improve the chin profile.

This approval expands the range of treatments offered by Allergan Aesthetics, aiming to address 90% of the facial area. JUVÉDERM® VOLUMA® XC is part of the JUVÉDERM® Collection of Fillers, which includes six products tailored for different areas of the face.

The information in this article is based on a press release statement from Allergan Aesthetics.

InvestingPro Insights

Allergan Aesthetics' parent company, AbbVie, has been making headlines with its recent FDA approval, but what does the financial data from InvestingPro tell us about the company's current market standing? With a robust market capitalization of 312.75 billion USD, AbbVie stands as a significant player in the biotechnology industry. The company's commitment to innovation and patient care, as demonstrated by the FDA approval for JUVÉDERM® VOLUMA® XC, is also reflected in its financials, showing a strong operating income margin of 32.51% over the last twelve months as of Q4 2023.

InvestingPro Tips highlight that AbbVie has raised its dividend for 11 consecutive years and is expected to see net income growth this year. These factors may be of particular interest to investors looking for stable returns and growth potential. Additionally, the company trades with relatively low price volatility, which could be appealing for those seeking less risky investment opportunities. For those interested in more comprehensive analysis, there are 14 additional InvestingPro Tips available, which can be accessed on the InvestingPro platform for AbbVie at https://www.investing.com/pro/ABBV.

Investors may also note that AbbVie is trading near its 52-week high, at 98.37% of this peak value, indicating a strong performance in the market. The company has provided a strong return over the last three months, with a price total return of 23.64%. Moreover, with an attractive dividend yield of 3.5% and a recent history of dividend growth, AbbVie could be a compelling option for dividend-seeking investors.

To delve deeper into the financial health and future outlook of AbbVie, use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription on InvestingPro.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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