New Class of Treatment for Overactive Bladder Approved in Europe

       New Class of Treatment for Overactive Bladder Approved in Europe

  PR Newswire

  CHERTSEY, England, January 11, 2013

CHERTSEY, England, January 11, 2013 /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

"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. ^[ ^1 ^5 ^]

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 β [3] -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 β [3] 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 21 ^st December 2012. In Japan, Astellas was granted
marketing approval under the trade name of BETANIS ^® 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


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.
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. 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 β3-adrenoceptor agonist, in patients with overactive
    bladder: results from a randomized European-Australian phase 3 trial. Eur
    Urol 2012;
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;
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 β3-adrenoceptor agonist, in overactive bladder. Eur Urol
    2012; 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

Contact: For further information please contact: Julia Holt, Red Door
Communications,, Tel: +44(0)20-8392-8052, Mobile:
+44(0)7788-441422; Mindy Dooa, Astellas Pharma Europe Ltd., Mobile: +44(0)7826-912-339
Press spacebar to pause and continue. Press esc to stop.