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Allergan Aesthetics Receives U.S. FDA Approval for SKINVIVE by JUVÉDERM® for the Improvement of Neck Appearance

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Allergan Aesthetics (NYSE: ABBV) received U.S. FDA approval for SKINVIVE by JUVÉDERM to improve neck appearance by reducing horizontal neck lines in adults over 21. This is its second indication after cheek skin smoothness.

SKINVIVE is the first and only FDA-approved hyaluronic acid injectable for neck lines, showing six-month results with optimal treatment and a mostly mild, transient safety profile.

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Positive

  • FDA approval for SKINVIVE by JUVÉDERM to improve adult neck appearance
  • First and only FDA-approved hyaluronic acid injectable for horizontal neck lines
  • 74.8% of treated participants achieved ≥1-point neck-line improvement at one month
  • 66% of participants maintained ≥1-point improvement in neck lines at six months
  • Minimally invasive treatment with ultrafine needle or cannula and little to no downtime
  • Results lasting six months with optimal treatment, including optional touch-up

Negative

  • Adverse events such as redness, bruising, swelling, and pain reported at injection sites
  • Severe adverse events occurred in less than 5% of participants reporting events
  • Safety and effectiveness in darker skin tone patients have not been studied for neck use
  • Provider training program required before purchase and administration of SKINVIVE
  • Broad commercial availability for the neck indication expected only later this year

News Market Reaction – ABBV

+0.40%
+0.40% Session close to close

In the Jun 16 session, ABBV gained 0.40%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement adds a second FDA-approved indication for SKINVIVE, extending its use from cheek s...
Analysis

This announcement adds a second FDA-approved indication for SKINVIVE, extending its use from cheek smoothness to neck lines in adults over 21. Clinical data showed 74.8% responders at one month and 66% maintaining benefit at six months, with severe adverse events in fewer than 5% of participants reporting AEs. Historically, AbbVie’s approval news has produced modest share-price changes, so investors may focus on uptake trends, safety consistency, and how aesthetics growth complements its larger oncology and immunology franchises.

Key Figures

One-month responder rate: 74.8% (78.5/105) Six-month responder rate: 66% (64/97) Severe adverse events: <5% (7/147 reporting AEs) +4 more
7 metrics
One-month responder rate 74.8% (78.5/105) Clinically significant ≥1-point ATNLS improvement at one month in pivotal study
Six-month responder rate 66% (64/97) Maintained ≥1-point improvement in horizontal neck lines at six months
Severe adverse events <5% (7/147 reporting AEs) Severe AEs among participants reporting adverse events in clinical study
Result duration 6 months Neck appearance improvement duration with optimal SKINVIVE treatment
Age criterion Adults over 21 Indicated population for neck appearance improvement
ATNLS scale grades 5 grades Validated 5-grade photonumeric Allergan Transverse Neck Lines Scale
Initial cheek approval year 2023 First FDA indication for SKINVIVE to improve cheek skin smoothness

Previous Fda approval Reports

5 past events · Latest: May 27 (Positive)
Same Type Pattern 5 events
Date Event Sentiment 24h Move Catalyst
May 27 Oncology FDA approval Positive +1.5% FDA approval of DECNUPAZ for ultra-rare BPDCN blood cancer.
Feb 20 CLL combo approval Positive +0.2% FDA approval of VENCLEXTA plus acalabrutinib for first-line CLL.
Nov 18 FL combo approval Positive -0.1% FDA approval of EPKINLY combo for relapsed or refractory FL.
Oct 13 Label update approval Positive -0.1% FDA approval of updated RINVOQ indication statement for IBD.
Jul 29 sNDA submission Positive +1.4% Submission for FDA approval of VENCLEXTA plus acalabrutinib in CLL.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent FDA approval headlines for ABBV have typically led to modest positive moves (average around 0.6%), but reactions have not been uniformly positive, with both up and down days recorded.

Recent Company History

Across the last five FDA approval-tagged events since July 2025, AbbVie has secured label expansions and new oncology approvals, including DECNUPAZ for BPDCN and VENCLEXTA-based regimens for CLL. These milestones broadened its hematology and immunology footprint. Price reactions were generally modest, with three small gains and two slight declines, underscoring that even meaningful regulatory wins have translated into limited short-term price impact. Today’s aesthetics-focused SKINVIVE approval fits the pattern of incremental portfolio expansion rather than a single dominant catalyst.

Key Terms

hyaluronic acid, lidocaine, adverse events, cannula, +2 more
6 terms
hyaluronic acid medical
"first and only hyaluronic acid injectable approved to reduce horizontal neck lines"
A naturally occurring molecule that acts like a tiny sponge, holding water in skin, joints and eyes to keep tissues plump and lubricated. Investors track products containing hyaluronic acid because they power large markets—such as skincare, injectable fillers, eye drops and wound treatments—so demand, regulatory approvals, manufacturing capacity and raw-material costs can meaningfully affect a company’s sales and profit outlook.
lidocaine medical
"The product contains a small amount of local anesthetic (lidocaine) to support patient comfort"
Lidocaine is a widely used local anesthetic that temporarily numbs tissue for minor procedures and a medicine also used to treat some heart rhythm problems; think of it as a targeted numbing agent or a reset for certain irregular heartbeats. Investors track lidocaine because its approvals, patent status, generic competition, manufacturing capacity and safety profile influence sales, pricing and supply for drugs and medical devices that contain it.
adverse events medical
"Participants in the clinical study reported experiencing adverse events (AEs) such as redness, bruising"
Adverse events are any harmful or unwanted medical occurrences experienced by people using a drug, device, or undergoing a treatment, whether or not the problem is caused by the product. Think of them as complaints or breakdowns noticed during a trial or after a product is on the market; regulators record and investigate them. Investors care because clusters or serious adverse events can delay approvals, trigger costly studies or recalls, change labeling, and quickly alter a company’s revenue and risk profile.
cannula medical
"treatment ... is administered using an ultrafine needle or cannula"
A cannula is a small, hollow tube that medical staff insert into the body to deliver or remove fluids, medications, or gases—think of it like a medical straw or connector used for IV lines, oxygen therapy, dialysis, or surgical access. Investors track cannulas because regulation, manufacturing capacity, product quality and clinical adoption of these basic but widely used devices can affect sales, reimbursement and the broader performance of companies in medical supplies and devices.
multicenter medical
"In the randomized, multicenter, evaluator-blinded, controlled pivotal clinical study"
A multicenter study or trial is conducted at several independent locations or clinics rather than a single site, so researchers collect data from diverse groups and settings. For investors, multicenter designs matter because they increase the credibility and generalizability of results, reduce the risk that findings are due to one local population or practice, and often speed enrollment — all factors that can affect regulatory outcomes, market confidence and commercial prospects.
evaluator-blinded medical
"randomized, multicenter, evaluator-blinded, controlled pivotal clinical study"
Evaluator-blinded means the people who measure or judge outcomes in a clinical study do not know which participants received the experimental treatment versus a control, which reduces conscious or unconscious bias in how results are recorded or interpreted. For investors, evaluator blinding increases confidence that reported benefits or side effects are real rather than influenced by expectations, making trial data more trustworthy when assessing a product’s commercial and regulatory prospects.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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  • SKINVIVE by JUVÉDERM® is now the first and only hyaluronic acid injectable approved to reduce horizontal neck lines caused by "tech-neck.1"
  • This is the second FDA-approved indication for SKINVIVE by JUVÉDERM®, which has been approved since 2023 to improve skin smoothness of the cheeks in adults.1

IRVINE, Calif., June 16, 2026 /PRNewswire/ -- Allergan Aesthetics, an AbbVie company (NYSE: ABBV), today announced the U.S. Food and Drug Administration (FDA) approval of SKINVIVE by JUVÉDERM® to reduce neck lines for the improvement of neck appearance in adults over the age of 21.1 With this approval, SKINVIVE by JUVÉDERM® is the first and only hyaluronic acid (HA) injectable indicated to reduce the appearance of neck wrinkles and help skin retain its natural moisture, leading to an improved neck appearance.1

Skinvive Logo

Neck wrinkles may develop due to natural aging, sun damage, weight loss, or "tech-neck" caused by the head-down position used for phones, tablets, and books.1 SKINVIVE by JUVÉDERM® reduces neck lines formed by tech-neck by helping the skin retain its natural moisture, softness, and smoothness.1 Treatment with SKINVIVE by JUVÉDERM® is minimally invasive with little to no downtime and is administered using an ultrafine needle or cannula. The product contains a small amount of local anesthetic (lidocaine) to support patient comfort during treatment. Results last six months with optimal treatment.1,*

"The approval of SKINVIVE by JUVÉDERM® for horizontal neck wrinkles reflects Allergan Aesthetics' commitment to developing science-driven innovations that address meaningful unmet aesthetic needs," said Darin Messina, Ph.D., senior vice president, aesthetics R&D, AbbVie. "This approval expands our portfolio of lower face and neck treatment options and gives patients and aesthetic providers a first-of-its-kind treatment option for improving neck skin quality and reducing the appearance of neck lines.1,3,*"

In the randomized, multicenter, evaluator-blinded, controlled pivotal clinical study, 74.8% (78.5/105) of participants treated in the neck with SKINVIVE by JUVÉDERM® saw clinically significant (≥ 1 point) improvement on the validated 5-grade photonumeric Allergan Transverse Neck Lines Scale (ATNLS) at one month.2,† Most participants (66% or 64/97) maintained ≥ 1 point improvement in horizontal neck lines at six months.2 Participants who demonstrated improvement from baseline in overall score stayed high (≥78%) at all timepoints during the study.2

Participants in the clinical study reported experiencing adverse events (AEs) such as redness, bruising, tenderness, lumps/bumps, swelling, firmness, pain, discoloration, and itching at the injection sites, as reported in their electronic diaries.1 These AEs were usually mild (causing little discomfort and no effect on daily activities), did not require treatment, and resolved within two weeks.1 Severe AEs were experienced by less than 5% of participants (7/147 reporting AEs).1 These AEs were reported similarly or less frequently after touch-ups and repeat treatments.1

As with some novel products, the FDA has required that Allergan Aesthetics provide a training program for all interested providers. Successful completion of this training is necessary prior to purchase of and administration of SKINVIVE by JUVÉDERM®. Allergan Aesthetics anticipates that SKINVIVE by JUVÉDERM® for the improvement of neck appearance will be broadly commercially available later this year.

To learn more about SKINVIVE by JUVÉDERM® visit www.skinvive.com and follow @skinvive on Instagram.

*Optimal treatment with SKINVIVE by JUVÉDERM® may require an optional touch-up one month after initial treatment to achieve the desired aesthetic outcome and is dependent on patient need.1

The safety and effectiveness of SKINVIVE by JUVÉDERM® neck treatment has not been studied in darker skin tone patients.

About Allergan Aesthetics 
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.allerganaesthetics.com

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Forward-Looking Statements 
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

SKINVIVE by JUVÉDERM® Injectable Gel Important Information

APPROVED USES
SKINVIVE by JUVÉDERM® injectable gel is an injection to improve skin smoothness of the cheeks in adults over the age of 21.

SKINVIVE by JUVÉDERM® injectable gel is an injection to reduce neck lines for improvement of neck appearance in adults over the age of 21.

IMPORTANT SAFETY INFORMATION
Are there any reasons why I should not receive SKINVIVE by JUVÉDERM® treatment?
Do not use this product if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), if you are allergic to lidocaine or the Gram-positive bacterial proteins used in this product, or if you have had previous allergic reactions to hyaluronic acid fillers.

What Warnings should my specialist advise me about?

  • One of the risks with dermal filler injections is the unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. Most of these events are irreversible. Tell your specialist immediately if you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment
  • The use of this product where skin sores, pimples, rashes, hives, cysts, or infections are present should be postponed, as this may delay healing or make skin problems worse
  • The effectiveness of removal of any dermal filler has not been studied

What Precautions should my specialist advise me about?

  • Avoid applying makeup for 12 hours after treatment. Minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment. Exposure to any of these may cause temporary redness, swelling, and/or itching at the injection site
  • Tell your specialist if you are using any medication that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners, as this may increase bruising or bleeding at the injection site
  • Tell your specialist if you are planning laser treatment, chemical peeling, or any other procedure after SKINVIVE by JUVÉDERM®. There is a possible risk of an inflammatory reaction at the treatment site
  • This product is intended for improving skin smoothness of the cheeks and reducing neck lines. The safety and effectiveness for treatment in other areas of the body have not been established
  • Tell your specialist if you are on therapy used to decrease the body's immune response, as treatment may result in an increased risk of infection
  • Tell your specialist if you are pregnant or breastfeeding. The safety for use during pregnancy, or in women who are breastfeeding, has not been studied
  • Tell your specialist if you have a history of excessive scarring (thick, hard scars). The safety of this product in patients with a history of excessive scarring has not been studied and may result in additional scars
  • Tell your specialist if you have a history of pigmentation disorders, as use of this product in patients with a history of pigmentation disorders has not been studied and may result in changes in pigmentation

What are the possible side effects of treatment?
The most commonly reported side effects were redness, lumps/bumps, swelling, bruising, pain, tenderness, firmness, discoloration and itching. Most side effects will resolve within 2 weeks. If they persist longer, your physician may choose to treat them with medications, such as antibiotics, steroids, or hyaluronidase. Additionally, there have been reports of inflammation, nodules, unsatisfactory result, loss or lack of improvement, allergic reaction, anxiety, blood vessel blockage, infection, dry skin, increase or decrease in sensation, and abscess.

Delayed-onset inflammation near the site of dermal filler injections is one of the known adverse events associated with dermal fillers. As with all skin injection procedures, there is a risk of infection.

To report a side effect, please call the Allergan® Product Support Department at 1-877-345-5372. Please also visit www.skinvive.com or talk to your specialist for more information.

SKINVIVE by JUVÉDERM® is available only by a licensed physician or properly licensed practitioner. See future update to be directed to the SKINVIVE by JUVÉDERM® Directions for Use and Patient Label.

© 2026 AbbVie. All rights reserved. SKINVIVE, JUVÉDERM, and its designs are trademarks of Allergan Holdings France SAS, an AbbVie company, or its affiliates. 

References

  1. SKINVIVE by JUVÉDERM® Patient Label. June 2026.
  2. SKINVIVE by JUVÉDERM® Directions for Use. June 2026.
  3. Data on File. REF-138623. Allergan Aesthetics. June 2025.

Contact(s)

Investors:
Liz Shea
Liz.Shea@AbbVie.com
(847) 935-2211

Media:
Ember Garrett
Ember.Garrett@Allergan.com
(714) 246-3525

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/allergan-aesthetics-receives-us-fda-approval-for-skinvive-by-juvederm-for-the-improvement-of-neck-appearance-302800848.html

SOURCE AbbVie

FAQ

What FDA approval did AbbVie (ABBV) receive for SKINVIVE by JUVÉDERM in June 2026?

AbbVie’s Allergan Aesthetics received FDA approval for SKINVIVE by JUVÉDERM to improve neck appearance by reducing horizontal neck lines in adults over 21. According to AbbVie, this is the product’s second indication after cheek skin smoothness.

How effective is SKINVIVE by JUVÉDERM for treating neck lines in ABBV’s clinical study?

SKINVIVE by JUVÉDERM showed clinically significant neck-line improvement for many participants. According to AbbVie, 74.8% achieved a ≥1-point improvement on a validated 5-grade neck-line scale at one month, and 66% maintained this improvement at six months.

What are the main side effects of SKINVIVE by JUVÉDERM neck treatment for ABBV investors to know?

Reported side effects were mostly injection-site reactions. According to AbbVie, participants experienced redness, bruising, tenderness, lumps or bumps, swelling, firmness, pain, discoloration, and itching, usually mild, not requiring treatment, and resolving within two weeks.

How long do SKINVIVE by JUVÉDERM neck treatment results last for AbbVie (ABBV) patients?

Results can last up to six months with optimal treatment. According to AbbVie, achieving desired aesthetic outcomes may require an optional touch-up one month after initial treatment, depending on individual patient needs and provider assessment.

Is SKINVIVE by JUVÉDERM the first hyaluronic acid injectable approved for neck lines?

Yes, SKINVIVE by JUVÉDERM is described as the first and only hyaluronic acid injectable approved to reduce horizontal neck lines. According to AbbVie, it helps skin retain natural moisture, softness, and smoothness, improving overall neck appearance.

When will SKINVIVE by JUVÉDERM for neck appearance be commercially available in the U.S.?

Allergan Aesthetics expects broad U.S. commercial availability later this year. According to AbbVie, providers must complete a required training program before purchasing and administering SKINVIVE by JUVÉDERM for neck treatment in adults.

Has SKINVIVE by JUVÉDERM neck treatment been studied in darker skin tone patients?

No, the neck indication has not been studied in darker skin tone patients. According to AbbVie, the safety and effectiveness of SKINVIVE by JUVÉDERM for neck treatment in this population remain unstudied, which may limit current clinical data generalizability.