MARKHAM, ON, March 8, 2013 /CNW/ - Astellas Pharma Canada, Inc., the
Canadian subsidiary of Tokyo-based Astellas Pharma Inc., announced
today Health Canada's approval of Myrbetriq™ (mirabegron,
Mirabegron is indicated for the treatment of overactive bladder (OAB)
with symptoms of urgency, urgency incontinence and urinary frequency.1 Mirabegron, a selective β3-adrenoceptor agonist, is a "first in class"
therapeutic agent with a mechanism of action distinct from
antimuscarinic agents2, the current treatment standard for OAB. β3-agonists relax the detrusor
smooth muscle during the storage phase of the urinary bladder fill-void
cycle, which increases bladder capacity.3
Dr. Sender Herschorn is Professor of Urology at the University of
Toronto, attending Urologist and Head of Urodynamics Laboratory at
Sunnybrook Health Sciences Centre and the general secretary of the
International Continence Society (ICS). He says many people who are
experiencing overactive bladder simply suffer in silence because they
are too embarrassed to discuss it with their physician.
"What these patients may not realize is that they don't just have to
live with overactive bladder," said Dr. Herschorn. "There are good
treatment options available that could significantly improve their
overall quality of life."
Mirabegron, approved in Japan (July 2011), the US (June 2012) and Europe
(December 2012), joins Vesicare (solifenacin succinate) in Astellas
Pharma Canada's OAB portfolio.
"Myrbetriq is the first in a new class of medications for the treatment
of OAB in over 30 years," said Michael Tremblay, President, Astellas
Pharma Canada. "Urological health continues to be a key priority for
Astellas and we are very pleased to be the first to offer Canadian
patients a new treatment option."
Myrbetriq was evaluated in three, 12-week, double-blind, randomized,
placebo-controlled, parallel group, multicenter clinical trials in
patients with overactive bladder with symptoms of urge urinary
incontinence, urgency, and urinary frequency. Entry criteria required
that patients had symptoms of overactive bladder for at least 3 months
duration, at least 8 micturitions per day, and at least 3 episodes of
urgency with or without incontinence over a 3 day period. The majority
of patients were Caucasian (94%) and female (72%) with a mean age of 59
years (range 18 - 95 years). The population included both naïve
patients who had not received prior antimuscarinic pharmacotherapy for
overactive bladder (48%) and those who had received prior
antimuscarinic pharmacotherapy for OAB (52%).
The co-primary efficacy endpoints in all 3 trials were (1) change from
baseline to end of treatment (Week 12) in mean number of incontinence
episodes per 24 hours and (2) change from baseline to end of treatment
(Week 12) in mean number of micturitions per 24 hours, based on a 3-day
ABOUT OVERACTIVE BLADDER
Overactive bladder (OAB) is a common condition defined as urgency, with
(OAB wet) or without urgency incontinence (OAB dry), usually associated
with increased daytime frequency and nocturia.5 In a recent Canadian population-based study, OAB symptoms were reported
in 13.9% of respondents (13.1% of men and 14.7% of women).6
ABOUT ASTELLAS PHARMA CANADA, INC.
Astellas Pharma Canada, Inc., headquartered in Markham, ON, is a
Canadian affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a
pharmaceutical company dedicated to improving the health of people
around the world through the provision of innovative and reliable
pharmaceutical products. The organization is committed to becoming a
global category leader in focused areas by combining outstanding R&D
and marketing capabilities. In Canada, Astellas has an intense
commercial focus on five therapeutic areas - Urology, Immunology,
Infectious Disease, Dermatology and Oncology. For more information
about Astellas Pharma Canada, Inc., please visit the corporate
1 Myrbetriq™ Canadian approved Product Monograph, dated March 4, 2013.
2 Nitti, V., Auerbach, S., Martin, N., Calhoun, A., Lee, M., Herschorn,
S., Results of a Randomized Phase III Trial of Mirabegron in Patients
with Overactive Bladder, The Journal of Urology® (2012), doi:
3 Aizawa, N., Igawa, Y., Nishizawa, O. et al.: Effects of CL316,243, a
beta 3-adrenoceptor agonist, and intravesical prostaglandin E2 on the
primary bladder afferent activity of the rat. Neurourol Urodyn, 29:
4 Myrbetriq™ Canadian approved Product Monograph, dated March 4, 2013.
5,6 Bettez M, Tu le M, Carlson K et al. Can Urol Assoc J 2012;6(5):354-63.
SOURCE: Astellas Pharma Canada, Inc.
For further information:
Astellas Pharma Canada, Inc.
Naomi Côté, Corporate Communications