DUBLIN, Oct. 2, 2015
/PRNewswire/ -- Allergan, plc (NYSE: AGN) is pleased to announce
that KYBELLA® (deoxycholic acid) injection, the first
and only FDA-approved injectable treatment for improving the
appearance of moderate to severe submental fullness, also known as
"double chin," received a "2015 Breakthrough Award" from Allure
Magazine. The publication honored KYBELLA®, along with
other winners from their annual "Best of Beauty" list, which
included hundreds of luxury, mass market and specialty beauty and
aesthetic brands, on September 21 at
an awards ceremony held at One World Trade Center in New York.
Logo - http://photos.prnewswire.com/prnh/20150612/222796LOGO
Products compete to receive the coveted beauty award, and
undergo rigorous analysis by Allure editors and top industry
experts such as dermatologists, cosmetic chemists and makeup
artists.
"It is an honor to receive this prestigious award and to have
KYBELLA® recognized as a beauty breakthrough by the world-renowned
experts at Allure," said David
Moatazedi, Vice President, Sales and Marketing U.S. Facial
Aesthetics at Allergan. "We are proud to offer men and women
seeking a non-surgical approach to improve their chin profile a
first-in-class aesthetic treatment with results supported by
science and high patient satisfaction."
As the first and only FDA-approved injectable drug that improves
the appearance of moderate to severe submental fullness due to
submental fat in adults, KYBELLA® has generated
significant interest from the aesthetic community, consumers and
the media since its FDA approval in April
2015.
KYBELLA® is administered by injections into the fat under the
chin, tailored to the overall treatment goals of the patient and
the physician. Patients are assessed before each treatment session;
this includes ensuring there is sufficient submental fat...[1] Up
to six treatments may be administered, which are typically 15-20
minute sessions scheduled at least one month apart. Once the
aesthetic response is achieved with KYBELLA®,
retreatment is not expected.
The most common adverse reactions were associated with the
injection site and included swelling, bruising, pain, numbness,
erythema and formation of areas of hardness around the treatment
area.
Health care practitioners and consumers can visit
www.mykybella.com for further product and prescribing
information.
Important Safety Information
KYBELLA® should only be administered by a trained
healthcare professional.
KYBELLA® is contraindicated in the presence of
infection at the injection sites.
Cases of marginal mandibular nerve injury, manifested as an
asymmetric smile or facial muscle weakness, were reported in 4% of
subjects in the clinical trials. KYBELLA® should not be
injected into or in close proximity to the marginal mandibular
branch of the facial nerve; all cases resolved spontaneously (range
1-298 days, median 44 days).
Dysphagia occurred in 2% of subjects in the clinical trials in
the setting of administration site reactions, e.g., pain, swelling,
and induration of the submental area; all cases of dysphagia
spontaneously resolved (range 1-81 days, median 3 days). Avoid use
of KYBELLA® in these patients as current or prior
history of dysphagia may exacerbate the condition.
In clinical trials, 72% of subjects treated with
KYBELLA® experienced hematoma/bruising.
KYBELLA® should be used with caution in patients with
bleeding abnormalities or who are currently being treated with
antiplatelet or anticoagulant therapy as excessive bleeding or
bruising in the treatment area may occur.
To avoid the potential of tissue damage, KYBELLA®
should not be injected into or in close proximity (1-1.5 cm) to
salivary glands, lymph nodes and muscles.
The most commonly reported adverse reactions in the pivotal
clinical trials were injection site edema/swelling,
hematoma/bruising, pain, numbness, erythema, and induration.
About Submental Fullness
Submental fullness, also referred to as double chin, is a common
yet under-treated condition that can detract from an otherwise
balanced and harmonious facial appearance[2] – leading to an older
and heavier look.[3] Submental fullness can affect adults – both
women and men – of all ages, weight and gender. Influenced by
multiple factors including aging and genetics, submental fullness
is often resistant to diet and exercise.
About KYBELLA®
KYBELLA® is the first and only approved
injectable drug for contouring moderate to severe submental
fullness, a condition that is commonly referred to as a double
chin. KYBELLA® is a non-human and non-animal
formulation of deoxycholic acid, a naturally-occurring molecule in
the body that aids in the breakdown and absorption of dietary
fat.[4] When injected into subcutaneous fat, KYBELLA®
causes the destruction of fat cells. Once destroyed, those cells
cannot store or accumulate fat.[5]
KYBELLA® (deoxycholic acid) injection is
indicated for improvement in the appearance of moderate to severe
convexity or fullness associated with submental fat in adults.
The safe and effective use of KYBELLA® for the
treatment of subcutaneous fat outside the submental region has not
been established and is not recommended.
About Allergan
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global
pharmaceutical company and a leader in a new industry model –
Growth Pharma. Allergan is focused on developing,
manufacturing and commercializing innovative branded
pharmaceuticals, high-quality generic and over-the-counter
medicines and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that
provide valuable treatments for the central nervous system, eye
care, medical aesthetics, gastroenterology, women's health,
urology, cardiovascular and anti-infective therapeutic categories,
and operates the world's third-largest global generics business,
providing patients around the globe with increased access to
affordable, high-quality medicines. Allergan is an industry leader
in research and development, with one of the broadest development
pipelines in the pharmaceutical industry and a leading position in
the submission of generic product applications globally.
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.
For more information, visit Allergan's website at
www.allergan.com.
Forward-Looking Statements
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 risks associated with acquisition
transactions; the difficulty of predicting the timing or outcome of
FDA and other regulatory 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 Quarterly
Report on Form 10-Q for the quarter ended June 30, 2015 (such periodic public filings
having been filed under the "Allergan plc" or "Actavis plc" names)
and from time to time in Allergan's other investor communications .
Except as expressly required by law, Allergan disclaims any intent
or obligation to update these forward-looking statements.
[1] KYBELLA Prescribing Information April 2015.
[2] Swift A, Remington K. BeautiPHication: a global approach to
facial beauty. Clin Plast Surg.
2011; 38:347-77.
[3] Dayan S. Neck rejuvenation. In: Hirsch, Aesthetic Rejuvenation:
A Regional Approach. 1st ed. New York,
NY: McGraw Hill Professional Publishing; 2008: 123-147.
[4] Stryer L, ed. Biochemistry. 4th Edition. New York, NY: WH Freeman and Co.; 1995:
691-707.
[5] FDA Approved Package Insert April
2015.
CONTACTS:
Investors:
Lisa DeFrancesco
(862) 261-7152
Media:
Mark Marmur
(862) 261-7558
Ember Garrett
(714) 246-3525
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SOURCE Allergan plc