New Class of Treatment for Overactive Bladder Approved in Europe

Chertsey, England (ots/PRNewswire) -

A new treatment, BETMIGA(TM) (mirabegron) has received approval
from the European Commission (EC) for the treatment of overactive
bladder (OAB) symptoms in adults.[1] Mirabegron represents the first
new class of oral treatment in OAB for over 30 years. Currently
around half of patients discontinue OAB treatment after only three
months, often due to lack of efficacy or side effects,[2],[3] so it
is important that doctors will now be able to offer patients an
alternative treatment that works in a different way.

OAB is defined as urinary urgency, with or without urgency
incontinence, usually with increased daytime frequency and nocturia
(waking up at night one or more times to empty the bladder).[4] OAB
affects more than 400 million people worldwide.[5] In Europe,OAB
affects approximately 17% of men and women and increases to 30-40%
for those aged over 75 years.[6] In a survey carried out in OAB
patients, 65% felt OAB had adversely affected their daily life.[6]
Symptoms can affect family, social and work life, as well as mental
and physical wellbeing,[7] and across OAB patients, depression scores
are higher, whilst quality of life scores are lower.[8]

Mirabegron will offer doctors an alternative to antimuscarinic
agents, the only other class of approved oral treatment previously
available for OAB. Mirabegron has a completely different mechanism of
action to antimuscarinics;[9] it improves the storage capacity of the
bladder without inhibiting bladder voiding, decreasing the number of
times patients need to visit the toilet.[10] Dry mouth is one of the
most common and bothersome side effects of antimuscarinics and often
the reason for discontinuation of treatment. In comparison, studies
have shown that mirabegron has a low incidence of
treatment-associated side effects, including dry
mouth.[9],[11],[12],[13],[14]

Dr Ayad Abdulahad, Vice President Medical Affairs and Health
Economics for Astellas Pharma Europe Ltd., commented: "This is an
important landmark highlighting Astellas' continued service to
patients with overactive bladder, and we are delighted to be able to
make a new treatment available to them. We know that many patients
discontinue their current treatments as a result of bothersome side
effects or because they simply don't feel they are getting a
worthwhile benefit. We really hope that Betmiga(TM) can help change
that and allow patients, whose lives are significantly disrupted by
OAB on a daily basis, the opportunity to think about something other
than their symptoms."

"The introduction of mirabegron should lead to a shift in how we
treat OAB symptoms in adults. It has been over 30 years since a new
class of oral treatment was available for OAB patients so we are
looking forward to being able to offer an effective medication
without the more bothersome side effects associated with
antimuscarinics," commented Professor Chris Chapple, Consultant
Urological Surgeon at Sheffield Teaching Hospitals and Lead
Investigator of the mirabegron 12 month safety and tolerability
study. "I see patients every day who are struggling to cope with this
chronic condition. OAB can have a significant impact on a patient's
quality of life. The introduction of mirabegron offers existing
patients and those newly diagnosed with OAB a real alternative to
current treatments."

The European Commission granted approval of mirabegron following
the recommendation by the Committee for the Medicinal Products for
Human Use (CHMP) in October 2012. They reviewed extensive clinical
trial evidence from 7 Phase II / III studies in which over 5,000
patients received mirabegron, including 3 Phase III double-blind,
randomised controlled trials conducted in the US and
Europe-Australia.[11],[12],[13] In the trials, mirabegron
demonstrated superior efficacy compared to placebo in the treatment
of symptoms of OAB, with patients needing to visit a toilet
significantly less frequently and experiencing fewer incontinence
episodes.[11],[12],[13] In the trials, mirabegron was also well
tolerated and exhibited a good safety profile.[11],[12],[13] In terms
of quality of life, research presented at the 2011 American
Urological Association (AUA) annual congress demonstrated that
patients with OAB who received mirabegron reported significant
improvements in treatment satisfaction, symptom bother, disease
perception and quality of life, in comparison with patients taking a
placebo.[15]

Astellas Pharma Europe Ltd. is an established leader in urology in
Europe, committed to improving the lives of patients with urological
conditions. Its current urology portfolio includes treatments for
benign prostatic hyperplasia (BPH), OAB and prostate cancer. With a
strong emphasis on research and development, Astellas is dedicated to
finding new treatments to meet unmet medical needs and has a number
of treatments for urological conditions in development. As part of
its ongoing commitment to the field, Astellas also provides and
supports a wide range of educational opportunities for those working
in the field of urology, designed to progress professional expertise
and improve patient outcomes.

About overactive bladder:

Overactive bladder (OAB) is characterised by symptoms of urinary
urgency, with or without urgency incontinence, usually with increased
daytime frequency and nocturia (awakening at night one or more times
to empty the bladder).[4]

About mirabegron:

Mirabegron is a once daily oral beta3-adrenoceptor agonist
discovered and developed by Astellas. It is the first compound
approved in this new class of treatment for OAB, using a novel
mechanism of action compared to antimuscarinics, the current
treatment standard.[8] Antimuscarinics work by binding to muscarinic
receptors in the bladder and inhibiting involuntary bladder
contractions. Mirabegron works by stimulating the beta3 receptors in
the muscle of the bladder causing relaxation of the bladder muscle,
improving the storage capacity of the bladder without impeding
bladder voiding.[10]

Astellas submitted a New Drug Application and Market Authorisation
Application for mirabegron to the U.S. Food and Drug Administration
and the European Medicines Agency in August 2011 and received FDA
approval on 28th June 2012, and European approval on 21st December
2012. In Japan, Astellas was granted marketing approval under the
trade name of BETANIS(R) tablet in July 2011. Additionally, there is
a recently completed multiregional Phase III study in China, Korea,
Taiwan, and India.

About Astellas Pharma Europe Ltd.:

Astellas Pharma Europe Ltd., located in the UK, is the European
headquarters 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 pharmaceuticals.
The organisation's focus is to deliver outstanding R&D and marketing
to continue growing in the world pharmaceutical market. Astellas
Pharma Europe Ltd. is responsible for 21 affiliate offices located
across Europe, the Middle East and Africa, an R&D site and three
manufacturing plants. The company employs approximately 4,300 staff
across these regions. For more information about Astellas Pharma
Europe, please visit http://www.astellas.eu.

References

1) Data on file
2) Benner J.S., Nichol M.B., Rovner E.S., et al. Patient-reported reasons for
discontinuing overactive bladder medication. BJU Int 2010; 105(9): 1276-82
3) Wagg A, Compion G, Fahey A, Siddiqui E. Persistence with prescribed
antimuscarinic therapy for overactive bladder: a UK experience. BJUI 2011.
Doi:10.1111/j.1464-410X.2012.11023.x
4) Abrams P. et al. Reviewing the ICS 2002 Terminology Report: The Ongoing
Debate. Neurourol Urodyn 2006; 25: 293-294
5) Irwin D.E., et al.Worldwide prevalence estimates of lower urinary tract
symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction.
[http://www.ncbi.nlm.nih.gov/pubmed/21231991 ]BJU Int 2011; 108(7):1132-8
6) Milsom I et al. How widespread are the symptoms of an overactive bladder and
how are they managed? A population-based prevalence study. BJU Int 2001;87(9)760-6
7) Brown J.S. et al. Comorbidities associated with overactive bladder. Am J
Manag Care 2000; 6(11 Suppl): S574-579
8) Stewart WF et al. Prevalence and burden of overactive bladder in the United
States. World J Urol 2003; 20: 327-336
9) Khullar V et al. Efficacy of mirabegron in patients with and without prior
anti-muscarinic therapy for overactive bladder (OAB): Post-hoc analysis of a
prospective, randomised European-Australian phase III trial. EAU 2012 Poster
AM12-2389 10) Tyagi P et al. Mirabegron: safety review Expert Opin. Drug Safety
2011;10.2: 287-294
11) Khullar V., Amarenco G., Angulo J.C., et al. Efficacy and safety of
mirabegron, a beta3-adrenoceptor agonist, in patients with overactive bladder:
results from a randomized European-Australian phase 3 trial. Eur Urol 2012;
http://dx.doi.org/10.1016/j.eururo.2012.10.016
12) Nitti V., Auerbach A., Martin N., et al. Results of a randomized phase III
trial of mirabegron in patients with overactive bladder. J Urol 2012;
10.1016/j.juro.2012.10.017
13) Van Kerrebroeck P, Barkin J, Castro-Diaz D et al. Randomised, double-blind,
placebo-controlled Phase III study to assess the efficacy and safety of mirabegron 25
mg and 50 mg once daily in overactive bladder (OAB). Presented at ICS 2012.
14) Chapple CR., Kaplan SK., Mitcheson D., et al. Randomized double-blind,
active-controlled phase 3 study to assess 12-month safety and efficacy of mirabegron,
a beta3-adrenoceptor agonist, in overactive bladder. Eur Urol 2012;
http://dx.doi.org/10.1016/j.eururo.2012.10.048
15) Nitti V et al. Mirabegron improves patient-reported outcomes in patients
with overactive bladder syndrome - results from a North-American study. Presented at
AUA 2011

ots Originaltext: Astellas Pharma Europe Limited
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For further information please contact: Julia Holt,
Red Door Communications, jholt@rdcomms.com, Tel: +44(0)20-8392-8052,
Mobile: +44(0)7788-441422; Mindy Dooa,
Astellas Pharma Europe Ltd., Mindy.Dooa@astellas.com
Mobile: +44(0)7826-912-339