Allergan (AGN) Announces Receipt of Additional Health Canada Approval for FIBRISTAL

November 21, 2016 8:06 AM EST

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Allergan plc (NYSE: AGN) announced 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.

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."



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