-- BELKYRA® is an individually-tailored,
injectable treatment that permanently destroys fat cells under the
chin(1) --
-- More than 67 per cent of people are bothered by
the fat or fullness under their chin, similar to the percentage of
patients who are bothered by lines and wrinkles(2)
--
-- Sweden acted as the Reference Member State for the
evaluation of BELKYRA® through a Decentralised Procedure involving
23 countries and is due to launch around Europe in the coming months --
DUBLIN, Oct. 13, 2016 /PRNewswire/ -- Allergan
plc (NYSE: AGN) a leading global pharmaceutical company,
announced that Sweden has received
the Marketing Authorisation for BELKYRA® (deoxycholic acid) after
being granted approval by the Swedish Medical Products Agency
(MPA). BELKYRA® is a prescription medicine 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.3 Fullness under the chin can impact how a
person feels about themselves and, for both women and men, can lead
to feelings of negative self-impression.4
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"BELKYRA® provides physicians with one of the first clinically
evaluated and approved treatments for their patients who are
bothered by fullness under the chin. We are very excited to receive
the marketing authorisation for BELKYRA® in Sweden and we are expecting more countries to
follow in the next months," said Bill
Meury, Chief Commercial Officer, Allergan. "We believe
BELKYRA® will be a breakthrough treatment in Europe, as it has been in the United States and Canada, and it complements our established
medical aesthetics portfolio. We look forward to introducing
BELKYRA® to other countries around Europe over the coming months, as we secure
the additional national approvals."
BELKYRA® is the only non-surgical injectable treatment for
reduction of fullness under the chin that has undergone rigorous
clinical evaluation, including four Phase 3 clinical studies
involving more than 2,600 patients worldwide.5 Until
now, treatment options for submental fullness have been limited to
surgical options such as liposuction and non-surgical in-clinic
procedures using handheld devices or aggressive weight-loss
regimens with potentially limited improvement.6 When
injected into fat under the chin, BELKYRA® permanently
causes the destruction of fat cells. Once destroyed, those cells
cannot store or accumulate fat.1
Fullness under the chin (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 was
one of the top troublesome conditions for patients, with 67%
reporting being concerned or bothered about the
condition.3 This is similar in number to the percentage
of people who are bothered by lines and wrinkles.3 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 ageing, genetics or weight
gain.7
"In my practice, I see many patients – both women and men – who
were bothered by their double chin but who were reluctant to
undergo surgery," said Shannon
Humphrey, Cosmetic Dermatologist at Carruthers &
Humphrey Cosmetic Dermatology, Vancouver,
Canada and BELKYRA® Clinical Investigator. "In the few
months since BELKYRA® was approved by Health Canada, many of my
current patients have started treatment, and it's also opened a
door for patients who have never seen an aesthetic practitioner
before but who are concerned about their double chin. BELKYRA® has
been a valuable addition to my treatment portfolio, as I can offer
patients new ways to achieve the results they desire."
Treatment with BELKYRA® takes place in-clinic by a
trained medical aesthetic physician. Many people experience
improvement after two to four treatment sessions spaced at least 4
weeks apart. A maximum of six treatments may be given.3
A patient's physician will carry out a full facial assessment to
help them determine how many treatment sessions they may need based
on the amount and distribution of the fat under their chin and
their personal treatment goals.3
Four phase III clinical studies have evaluated the efficacy and
safety of BELKYRA® in adults with moderate-to-severe
fullness under the chin; two in North
America and two in Europe.3 In these studies,
BELKYRA® was shown to have a high overall efficacy rate,
demonstrated by a 1-grade improvement in fullness under the chin as
assessed by the clinician in the study at 12 weeks after the last
treatment (63.8% in European studies and 78.5% in the North
American studies, respectively). 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 the fullness under their chin (compared
with 18% and 17.3% of people treated with placebo, respectively)
during the same time period.3 In the clinical studies,
BELKYRA® was generally well tolerated. Most side effects
(including injection site pain/swelling and bruising) were mild or
moderate in severity, primarily associated with the treatment area
and resolved without intervention.8
As a next step, Allergan will begin to train appropriate
healthcare professionals on the safe and effective use of this new
treatment to ensure optimal patient satisfaction and outcomes.
BELKYRA® was evaluated through a Decentralised Procedure, with
the Swedish agency (MPA) acting as the Reference Member State and
included 20 other countries in the European Union, as well as
Iceland and Norway. Allergan will continue to work
with other health regulatory agencies around the world to bring
this valuable treatment option to people with fullness under the
chin. BELKYRA® is already licensed in Canada, Australia, Iceland, Hungary, Austria, Lithuania, Estonia, Latvia, Romania, Bulgaria and Norway, as well as in the U.S. as
KYBELLA®.
Note to Editors:
Countries Involved in the
Decentralised Procedure
For BELKYRA®, Sweden served 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 has now received the Marketing
Authorisation in Iceland,
Hungary, Austria, Lithuania, Estonia, Latvia, Romania, Bulgaria and Norway. Allergan will launch the product in
the other cluster of countries in the latter half of 2016 or early
2017, following additional approvals.
About Submental Fullness (or double chin)
Fullness
under the chin, or a double chin, can detract from an otherwise
balanced and harmonious facial appearance 9 frequently
leading to an older and heavier look which can impact how a person
feels about themselves and lead to feelings of negative
self-impression.4 The condition can affect adults – both
women and men – of all ages, weight and gender. Influenced by
multiple factors including ageing and genetics, fullness under the
chin is often resistant to diet and exercise.7,10
About BELKYRA®
BELKYRA®
contains a synthetic version of deoxycholic acid1 which
imitates naturally-occurring deoxycholic
acid.2 When injected into subcutaneous fat,
BELKYRA® causes the destruction of fat
cells.1 Once destroyed, those cells cannot store or
accumulate fat.1
About Allergan
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.
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
- 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, pp445–453
- American Society for Dermatologic Surgery (ASDS). 2015 ASDS
Consumer Survey on Cosmetic Dermatologic Procedures. April 2015.
- BELKYRA® Summary of Product Characteristics.
- Ascher B, et al Efficacy, patient-reported outcomes and safety
profile of ATX-101 (deoxycholic acid), an injectable drug for the
reduction of unwanted submental fat: results from a phase III,
randomized, placebo-controlled study. Journal of the European
Academy of Dermatology and Venereology. 2014; 28(12)
- Belkyra Data on File 01: INT/0532/2016
- McDiarmid J. Results from a Pooled Analysis of Two European,
randomized, Placebo-Controlled, Phase 3 Studies of ATX-101 for the
Pharmacologic Reduction of Excess Submental Fat. Aesthetic Plastic
Surgery. 2014; 38(5)
- DeFatta R, Ducic Y. Liposuction of the face and neck.
Operative Techniques in Otolaryngology. 2007;
18:261-266.
- Allergan Data on file 02: INT/0533/2016
- Rohrich R, et al. Neck Rejuvenation Revisited. Plastic and
Reconstructive Surgery. 2006; 118, Number 5.
- Schlessinger J et al, Perceptions and Practices in Submental
Fat Treatment: A Survey of Physicians and Patients. SKINmed.
2013;11:27-31
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