-- BELKYRA® (deoxycholic acid) expected to be
the first non-surgical prescription medicine to treat submental
fullness (or double chin) to be authorised in 21
European Union Member States as well as Iceland and Norway --
DUBLIN, July 1, 2016 /PRNewswire/ -- Allergan plc
(NYSE: AGN), a leading global pharmaceutical company, today
announced that it has received a Positive Opinion from the Swedish
Medical Products Agency (MPA) for BELKYRA® (deoxycholic
acid). BELKYRA® will be the first prescription medicine
to be licensed in Europe for the
treatment of moderate to severe convexity or fullness associated
with submental fat (often called double chin) in adults when the
presence of submental fat has a psychological impact for the
patient.1 BELKYRA® is being evaluated through
the Decentralised Procedure, with the Swedish MPA acting as the
Reference Member State for 20 other countries in the European
Union, as well as Iceland and
Norway.
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"We are delighted to receive the Positive Opinion from
the Swedish Medical Products Agency (MPA) for
BELKYRA®, which provides men and women who are
bothered by submental fullness with a new minimally
invasive treatment option," said David
Nicholson, Chief R&D Officer at Allergan. "Because of
the extensive evidence behind the product, we see
BELKYRA® as a breakthrough treatment that will
complement other aesthetic treatments. We look forward to our
continued work with the 20 EU member states, Norway and Iceland to secure marketing authorizations to
make this important new treatment option available to customers and
patients."
Submental fullness (or double chin) is a concern for many
people. In fact, according to data from the American Society for
Dermatologic Surgery (ASDS) in 2015, fat under the chin/neck topped
the list of most troublesome conditions for patients, with 67%
reporting being concerned or bothered about the
condition.2 There is a common misperception that
fullness under the chin only appears in those who are overweight,
when in reality it can occur in any body type and may be related to
aging, genetics or weight gain.3
"In my practice, I see many patients – both men and women –
whose self-esteem has been negatively impacted by fullness under
their chin; often the way they feel on the inside is contrary to
what they see when they look in the mirror," said Leading Cosmetic
Physician David Eccleston. "I would welcome the addition of a
minimally invasive, clinically proven, authorized prescription
medicine that meets Good Manufacturing Practice Standards to my
practice, and it would give me confidence to be able to offer an
effective and proven solution for double chin (submental fullness)
to my patients."
"Once approved, BELKYRA® will provide a complementary
fit to our broader medical aesthetics portfolio. We are looking
forward to bringing the product to market and training physicians
on how to best use this new treatment," said Paul Navarre, President, Allergan
International.
BELKYRA® has been the focus of a global clinical
development programme involving over 20 clinical studies with more
than 2,600 patients worldwide.4 Four phase III clinical
studies have assessed the efficacy and safety of
BELKYRA® in adults with moderate to severe fullness
under the chin; two in the US and two in Europe.1 In the clinical studies,
clinicians assessed that 63.8% of people treated with
BELKYRA® in the European studies and 78.5% of patients
in the North America studies
achieved a 1-grade improvement in the appearance of the area
beneath their chin at 12 weeks after their last treatment.
Importantly, 44.6% of people treated with BELKYRA® in
the European studies and 48.6% in the North American studies
reported improvement in the psychological impact due to their
submental fullness (compared with 18% and 17.3% of people treated
with placebo, respectively) during the same time
period.1 BELKYRA® was generally well
tolerated. Most side effects were mild or moderate in severity,
primarily associated with the treatment area and resolved without
intervention.5
As a next step, Allergan will work to secure the national
Marketing Authorisations in the Concerned Member States. Once the
national licenses have been granted, Allergan will begin to train
healthcare professional customers on the safe and effective use of
this new treatment. Allergan is already working with other health
regulatory agencies around the world to bring this valuable
treatment option to people with submental fullness.
BELKYRA® is already licensed in Canada, as well as in the U.S. as
KYBELLA®.
Note to Editors:
About Submental Fullness
A
double chin is a common yet undertreated condition that can detract
from an otherwise balanced and harmonious facial appearance –
frequently leading to an older and heavier look.6
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.3,7 Submental fullness is the
result of aging on the foundation of the skin, muscle, bone and
fat.6
Countries Involved in the Decentralised Procedure
For
BELKYRA®, Sweden serves
as the Reference Member State in the Decentralised Procedure. The
other 22 Concerned Member States are Austria, Bulgaria, Cyprus, Czech
Republic, Estonia,
Finland, France, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovenia, Slovakia and Spain. Allergan expects to finalise the
Marketing Authorisations and launch the product in most of these
countries in the latter half of 2016 or early 2017.
About BELKYRA®
BELKYRA®
contains a non-human, non-animal version of deoxycholic acid which
is identical to naturally-occurring deoxycholic acid. When injected
into subcutaneous fat, BELKYRA® causes the destruction
of fat cells. Once destroyed, those cells cannot store or
accumulate fat, so re-treatment is not expected once the patient's
treatment goal is achieved.1
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 commercialising 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.
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, 2015 and Quarterly
Report on Form 10-Q for the quarter ended March 31,
2016 (such periodic public filings having been filed under the
"Actavis plc" name). Except as expressly required by
law, Allergan disclaims any intent or obligation to
update these forward-looking statements.
References
1 BELKYRA® Summary of Product Characteristics. EU
2 American Society for Dermatologic Surgery (ASDS). 2015
ASDS Consumer Survey on Cosmetic Dermatologic
Procedures. April 2015.
3 DeFatta R, Ducic Y. Liposuction of the face and neck.
Operative Techniques in Otolaryngology. 2007;
18:261-266.
4 Data on File: NDA Section 5.1, page 18.
5 BELKYRA® summary of clinical safety, pgs 61-62
6 Rzany B et al. Reduction of unwanted submental fat
with ATX-101 (deoxycholic acid), an adipocytolytic injectable
treatment: results from a phase III, randomized, placebo-controlled
study. British Journal of Dermatology (2014) 170,
445–453.
7 Schlessinger J, et al. Perceptions and Practices in
Submental Fat Treatment: A Survey of Physicians and Patients.
SKINMed 2013. 11:27-31
CONTACTS:
Allergan
Investors:
Lisa
DeFrancesco
+1 (862) 261-7152
Media:
Mark Marmur
(U.S.)
+1 (862) 261-7558
Janet Kettels (Int'l)
+44 (0)7738 506 476