— FIBRISTAL® shown to significantly
control heavy uterine bleeding, shrink fibroid volume and reduce
pelvic pain for patients suffering from uterine
fibroids1 —
DUBLIN and MARKHAM, Ontario, Nov.
21, 2016 /CNW/ -- Allergan plc (NYSE: AGN)
announced today that it has received an additional approval from
Health Canada for FIBRISTAL® (ulipristal acetate, 5 mg)
for the intermittent treatment of moderate to severe signs and
symptoms of uterine fibroids in adult women of reproductive age.
Each treatment course is three months,2 given in
repeated courses.
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A once-daily oral medication, FIBRISTAL® is the first
and only non-surgical treatment specifically indicated to treat the
signs and symptoms of uterine fibroids. In long term clinical
studies FIBRISTAL® was shown to safely and effectively
control excessive uterine bleeding, shrink fibroid volume and
reduce the significant pain and symptom severity scores associated
with symptomatic uterine fibroids.3,4 These benefits
appear to improve over repeated courses, returning patients'
quality of life measures back to levels of healthy women.
"For patients who wish to avoid surgery or retain their
fertility, FIBRISTAL® is now a viable option," said Dr.
Sony S Singh, MD, FRCSC, Associate Professor and Vice Chair of
Gynaecology at The Ottawa Hospital and University of Ottawa. "FIBRISTAL®
specifically targets fibroids and improves heavy bleeding and other
symptoms related to this common and debilitating condition. The
other benefit is that this medication has been shown to be well
tolerated among most women as it doesn't induce menopause."
FIBRISTAL® was first approved in 2013 but now the
indication for the treatment of signs and symptoms of uterine
fibroids has broadened with the addition of long term safety and
efficacy studies. The Society of Obstetricians and Gynecologists of
Canada (SOGC) has recently updated
its clinical practice guidelines to include ulipristal acetate. The
SOGC noted its strong scientific evidence for control of abnormal
uterine bleeding, rapid onset of action, anemia correction and
reduction in bulk symptoms.5
"The approval of FIBRISTAL® for long term
intermittent use is an important step in changing the lives of
Canadian women who live with this challenging condition and need a
highly effective and safe medical therapy option," said
Ed Gudaitis, General Manager at
Allergan Canada. "The evolution of this new medication demonstrates
an innovative alternative in the standard of care for uterine
fibroids, Allergan's commitment to improving women's health, and we
look forward to continuing to bring innovative medicines to women
of all ages."
About uterine fibroids
Seventy to eighty per cent of
Canadian women of reproductive age have uterine fibroids, which are
the leading cause of hysterectomies in Canada.6 The most common symptom of
uterine fibroids is abnormal uterine bleeding, which causes pain
and heavy, prolonged periods.7 If left untreated,
uterine fibroids can impact fertility and cause complications
during pregnancy.8 In a Canadian survey of over 11,000
women aged 20 to 49, those who had uterine fibroids with moderate
to severe symptoms experienced a significantly heavier burden of
illness, lost productivity and reduced quality of life.9
Symptoms of uterine fibroids usually resolve with menopause, at
which time treatments are stopped.
About FIBRISTAL®
FIBRISTAL®
belongs to a class of medications called selective progesterone
receptor modulators (SPRMs). It is an oral partial progesterone
antagonist that exerts a direct effect on the endometrium to
control excessive bleeding, and on fibroids where it inhibits cell
proliferation and induces apoptosis (cell death) to reduce their
size.10 A treatment course is three months of
continuous use followed by a treatment-free interval of two
menstrual cycles and continued with intermittent courses as
necessary.11
The efficacy of FIBRISTAL® was evaluated in two
long-term Phase III studies, PEARL III and PEARL IV, involving 132
and 451 patients respectively. Both studies confirmed the efficacy
and safety of the intermittent long term use of
FIBRISTAL®.12,13
The results of the PEARL IV study included control of uterine
bleeding, reduction in fibroid volume, reduction in pelvic pain,
correction in anemia and improvement in quality of life. The most
common adverse drug reactions (≥ 5 per cent) in the clinical trials
for women receiving FIBRISTAL® were hot flashes and
headaches. The vast majority of adverse drug reactions were mild or
moderate, decreased with repeated courses, and did not lead to
discontinuation of the medication.14
To date, more than 300,000 women in 57 countries have been
treated with FIBRISTAL®.15
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.
About Allergan in Canada
For more information, visit
Allergan Canada's website at www.Allergan.ca
Forward-Looking Statement
Statements contained in this
press release referring 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 June 30, 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 Donnez,
J; Hudecek, R; Donnez, O. et al. Efficacy and Safety of repeated
use of ulipristal acetate in uterine fibroids. Fertil Steril
2015; 103(2):519-27.
2 FIBRISTAL® Product Monograph, November 7, 2016.
3 Donnez J, Vazquez F, Tomaszewski J, et al. Long-term
treatment of uterine fibroids with ulipristal acetate. Fertil
Steril 2014;101(6):1565-73.
4 Donnez, J; Hudecek, R; Donnez, O. et al. Efficacy and
Safety of repeated use of ulipristal acetate in uterine fibroids.
Fertil Steril 2015; 103(2):519-27.
5 Vilos GA et al. SOGC Clinical Practice
Guidelines: The Management of Uterine Leiomyomas: Introduction and
Medical Management. J Obstet Gynaecol Can
2015;37(2):157-178.
6 Vilos GA et al. SOGC Clinical Practice
Guidelines: The Management of Uterine Leiomyomas: Introduction and
Medical Management. J Obstet Gynaecol Can
2015;37(2):157-178.
7 Vilos GA et al. SOGC Clinical Practice
Guidelines: The Management of Uterine Leiomyomas: Introduction and
Medical Management. J Obstet Gynaecol Can
2015;37(2):157-178.
8 Carranza-mamane B, Havelock J, Hemmings R, et al, et
al. The management of uterine fibroids in women with otherwise
unexplained infertility. J Obstet Gynaecol Can.
2015;37(3):277-88.
9 Vilos GA et al. SOGC Clinical Practice
Guidelines: The Management of Uterine Leiomyomas: Introduction and
Medical Management. J Obstet Gynaecol Can
2015;37(2):157-178.
10 FIBRISTAL® Product
Monograph, November 7, 2016.
11 FIBRISTAL® Product
Monograph, November 7, 2016.
12 Donnez J, Vazquez F, Tomaszewski J, et al. Long-term
treatment of uterine fibroids with ulipristal acetate. Fertil
Steril 2014;101(6):1565-73.
13 Donnez, J; Hudecek, R; Donnez, O. et al. Efficacy and
Safety of repeated use of ulipristal acetate in uterine fibroids.
Fertil Steril 2015; 103(2):519-27.
14 FIBRISTAL® Product Monograph, November 7, 2016.
15 Allergan data on file.
Investors:
Lisa DeFrancesco
(862) 261-7152
Media:
Janet Kettels,
Allergan
+44 7738 506 476
Mark Marmur, Allergan
(862) 261-7558
Alexandra Fahmey, Edelman
(416) 849-1958
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SOURCE Allergan plc