Allergan Release: FIBRISTAL, The First And Only Medication Indicated For Uterine Fibroids, Receives Approval From Health Canada For Long Term Intermittent Treatment

November 21, 2016 |

8 min read

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 /PRNewswire/ -- 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
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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 GynaecolCan. 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.