DUBLIN, March 20, 2017 /PRNewswire/ -- Allergan plc,
(NYSE: AGN), a leading global pharmaceutical company, today
announced that the company has received approval from the U.S. Food
and Drug Administration (FDA) to market JUVÉDERM VOLLURE™ XC, for
correction of moderate to severe facial wrinkles and folds, such as
nasolabial folds, in adults over the age of 21.1 In the
US pivotal clinical trial, a majority (59%) of subjects saw
improvement in moderate to severe nasolabial folds for up to 18
months.* Patient satisfaction in the pivotal study was also high:
82% of patients said they were very satisfied at 6 months and 68%
at 18 months.2
"The FDA approval of JUVÉDERM VOLLURE™ XC demonstrates
Allergan's imperative to develop next-generation HA fillers
designed to meet different patient needs," said David Nicholson, Chief Research and Development
Officer at Allergan. "This commitment to ongoing scientific
research and development is one of the factors that make
JUVÉDERM®, the number one selling collection of dermal
filler products."3
JUVÉDERM VOLLURE™ XC is formulated with Allergan's proprietary
VYCROSS® technology, which blends different molecular
weights of hyaluronic acid, contributing to the gel's
duration.4† Our first product featuring
VYCROSS® technology, JUVÉDERM VOLUMA® XC, was
FDA-approved to increase volume lost due to aging in the cheek
area,5 followed by JUVÉDERM VOLBELLA® XC,
FDA-approved for lip augmentation and correction of perioral
rhytids.6
Now with JUVÉDERM VOLLURE™ XC, the advanced VYCROSS®
technology yields a custom engineered injectable gel product which
was studied in the nasolabial folds, the number one dermal
treatment area. It delivers a long-lasting result, up to 18
months*, that patients appreciate.2,4,7
JUVÉDERM VOLLURE XC™ is specifically tailored with a balance of
gel firmness and low cohesivity, yielding a versatile formulation
that adds subtle volume for the correction of moderate to severe
facial wrinkles and folds.2,4 "What's exciting about
JUVÉDERM VOLLURE™ XC is that it was shown to last up to 18 months
from the initial or touch-up injection in a majority of subjects,
which is the longest lasting result shown in a clinical study in
the nasolabial folds,"2 said Dr. Joely Kaufman, a board-certified dermatologist
and clinical trial investigator. "As the number of patients seeking
dermal filler treatments continues to grow,7 I am
pleased that the technology created by Allergan has also followed
that same trend, with a full range of products that will allow for
tailoring of treatment based on specific patient needs."
The most common side effects seen in the clinical study were
temporary injection site responses at the treatment site such as
swelling, tenderness, bruising, firmness lumps/bumps, redness,
pain, discoloration, and itching. Most of these side effects
resolved within 1 week.2
JUVÉDERM VOLLURE™ XC was first approved in Europe as JUVÉDERM VOLIFT® in 2013.
The JUVÉDERM® family of products is marketed and sold in
more than 80 countries outside the United
States.
JUVÉDERM VOLLURE™ XC will be available to physicians in
April 2017. For more information
about JUVÉDERM VOLLURE™ XC and the JUVÉDERM® Collection
of fillers or to find a doctor, please visit www.juvederm.com.
JUVÉDERM VOLLURE™ XC Important Information
APPROVED USES
JUVÉDERM VOLLURE™ XC injectable gel is
for injection into the facial tissue for the correction of moderate
to severe facial wrinkles and folds, such as nasolabial folds in
adults over the age of 21.
IMPORTANT SAFETY INFORMATION
Are there any reasons why I should not receive JUVÉDERM
VOLLURE™ XC injectable gel?
Do not use this product
if you have a history of multiple severe allergies or severe
allergic reactions (anaphylaxis), or if you are allergic to
lidocaine or the Gram-positive bacterial proteins used in this
product.
What precautions should my doctor advise me about?
- Tell your doctor if you are pregnant or breastfeeding. The
safety of this product for use during pregnancy or while
breastfeeding has not been studied
- The safety of JUVÉDERM VOLLURE™ XC in patients under 22 years
has not been studied
- The safety and effectiveness of JUVÉDERM VOLLURE™ XC in areas
other than facial wrinkles and folds have not been established in
clinical studies
- Tell your doctor if you have a history of excessive scarring
(e.g., hypertrophic scarring and keloid formations) or pigmentation
disorders, as use of this product may result in additional scars or
changes in pigmentation
- Tell your doctor if you are planning other laser treatments or
a chemical peel, as there is a possible risk of inflammation at the
treatment site if these procedures are performed after
treatment
- Patients who experience skin injury near the site of injection
with this product may be at a higher risk for side effects
- Tell your doctor if you are on immunosuppressive therapy used
to decrease the body's immune response, as use of this product may
result in an increased risk of infection
- Tell your doctor if you are using medications that can prolong
bleeding, such as aspirin, ibuprofen, or other blood thinners, as
this may result in increased bruising or bleeding at the injection
site
- Minimize strenuous exercise, exposure to extensive sun or heat,
and alcoholic beverages within the first 24 hours following
treatment
What are possible side effects?
The most commonly
reported side effects with JUVÉDERM VOLLURE™ XC injectable gel
included injection-site redness, swelling, pain, tenderness,
firmness, lumps/bumps, bruising, discoloration, and itching. Most
side effects were mild or moderate and lasted 7 days or less.
One of the risks with using this product is unintentional
injection into a blood vessel, and, while rare, 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.
As with all skin injection procedures, there is a risk of
infection.
To report a side effect with JUVÉDERM VOLLURE™ XC
please call Allergan at 1-800-433-8871. Please visit
Juvederm.com or talk to your doctor for more information.
Available by prescription only.
* Including optional touch up at 1 month for optimal
correction
† Gel properties assessed with in vitro studies.
Clinical significance is unknown.
1. JUVÉDERM VOLLURE™ XC Directions for Use, 2017.
2. JUVÉDERM VOLLURE™ XC Patient Labeling, 2017.
3. Data On File Allergan, Inc.; Proforma Sales JUVÉDERM
VOLUMA® XC, 2015.
4. Bernardin A et al. VYCROSS ®: An innovative dermal filler
technology. Poster presented at: 1st Annual Anti-Aging Medicine
European Congress (AMEC ); October 11-12,
2013; Paris, France
5. JUVÉDERM VOLUMA® XC Directions for Use, 2013.
6. JUVÉDERM VOLBELLA® XC Directions for Use, 2016.
7. Data On File Allergan, Inc.; Facial Injectables Patient Records
Tracking Study – Fillers, 2016.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global
pharmaceutical company and a leader in a new industry model –
Growth Pharma. Allergan is focused on developing, manufacturing and
commercializing branded pharmaceuticals, devices and biologic
products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class
products for the central nervous system, eye care, medical
aesthetics and dermatology, gastroenterology, women's health,
urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, the Company's
R&D model, which defines our approach to identifying and
developing game-changing ideas and innovation for better patient
care. This approach has led to Allergan building one of the
broadest development pipelines in the pharmaceutical industry with
70+ mid-to-late stage pipeline programs in development.
Our Company's success is powered by our more than 16,000 global
colleagues' commitment to being Bold for Life. Together, we build
bridges, power ideas, act fast and drive results for our customers
and patients around the world by always doing what is right.
With commercial operations in approximately 100 countries,
Allergan is committed to working with physicians, healthcare
providers and patients to deliver innovative and meaningful
treatments that help people around the world live longer, healthier
lives every day.
For more information, visit Allergan's website at
www.Allergan.com.
Allergan Forward-Looking Statement
Statements contained in this press release that refer to future
events or other non-historical facts are forward-looking statements
that reflect Allergan's current perspective of existing trends and
information as of the date of this release. Except as expressly
required by law, Allergan disclaims any intent or obligation to
update these forward-looking statements. Actual results may differ
materially from Allergan's current expectations depending upon a
number of factors affecting Allergan's business. These factors
include, among others, the difficulty of predicting the timing or
outcome of FDA approvals or actions, if any; the impact of
competitive products and pricing; market acceptance of and
continued demand for Allergan's products; difficulties or delays in
manufacturing; and other risks and uncertainties detailed in
Allergan's periodic public filings with the Securities and Exchange
Commission, including but not limited to Allergan's Annual Report
on Form 10-K for the year ended December 31,
2016. Except as expressly required by law, Allergan
disclaims any intent or obligation to update these forward-looking
statements.
© 2017 Allergan. All rights reserved. All trademarks are the
property of their respective owners.
CONTACTS:
Investors:
Karina Calzadilla
(862) 261-7558
Media:
Mark Marmur
(862) 261-7558
Ember Garrett
(714) 246-3525
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