Mirabegron Receives Positive CHMP Opinion for Treatment of Overactive Bladder Symptoms

Chertsey, England (ots/PRNewswire) -

ASTELLAS PHARMA EUROPE Ltd. announced today that the Committee
for Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) has adopted a positive opinion, recommending the
granting of a marketing authorisation for BETMIGA[TM] (mirabegron)
for the symptomatic treatment of urgency, increased micturition
frequency and/or urgency incontinence as may occur in adult patients
with overactive bladder (OAB) syndrome.

The opinion now needs ratification by decision of the European
Commission which is expected within the next 74-90 days. If approved,
mirabegron will be the first in a new class of OAB treatment,
offering healthcare professionals an alternative option to
antimuscarinics (currently the only licensed oral treatment option)
when treating patients with OAB.

Mirabegron is a once daily oral beta3-adrenoceptor agonist with a
distinct mechanism of action compared to antimuscarinics, the current
treatment standard.[1] Antimuscarinics work by binding to muscarinic
receptors in the bladder and inhibiting involuntary bladder
contractions. Mirabegron works by stimulating the beta3 receptors in
the detrusor muscle of the bladder[2] causing relaxation of the
bladder muscle during the storage phase of the micturition cycle.
This improves the storage capacity of the bladder without inhibiting
bladder voiding.[3]

The positive opinion was reached after the CHMP reviewed
comprehensive clinical trial evidence from 7 phase II / III studies
in which over 5,000 patients received mirabegron, including three
Phase III double-blind, randomised controlled trials conducted in the
US and Europe-Australia.[4],[5],[6] 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.[4],[5],[ 6] In terms of quality of life, treatment of the
symptoms of OAB with mirabegron once daily has also demonstrated
statistically significant improvements over placebo on quality of
life measures such as treatment satisfaction and symptom bother.[7]

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), overactive bladder
(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.

Notes to editors

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).[8]

OAB is a common condition. A survey of over 16,000 adult men and
women in six European countries revealed that 17% of respondents had
symptoms of OAB.[9] Prevalence of OAB increases with age, with 30% to
40% of those aged over 75 years affected.[9] OAB can also have a
major impact on quality of life. In the survey, a majority (65%) of
respondents indicated their daily lives were adversely affected.[9]

About mirabegron

Mirabegron is a once daily oral beta3-adrenoceptor agonist
discovered and developed by Astellas. It is the first compound
submitted for regulatory approval in this new class of treatment for
OAB, using a distinct mechanism of action compared to
antimuscarinics, the current treatment standard.[1] Antimuscarinics
work by binding to muscarinic receptors in the bladder and inhibiting
involuntary bladder contractions. Mirabegron works by stimulating the
beta3 receptors in the detrusor muscle of the bladder causing
relaxation of the bladder muscle during the storage phase of the
micturition cycle.[2] This improves the storage capacity of the
bladder without impeding bladder voiding.[3]

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 CHMP opinion today. 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) Khullar V et al. Efficacy of mirabegron in patients with and without
prior antimuscarinic therapy for overactive bladder (OAB): Post-hoc analysis of a
prospective, randomised European-Australian phase III trial. EAU 2012 Abstract
AM12-2389: 684
2) Takasu T et al. Effect of (R)-2-(2-aminothiazol-4-yl)-4?-{2-[(
2-hydroxy-2-phenylethyl)amino]ethyl} acetanilide (YM178), a novel selective
beta3-adrenoceptor agonist, on bladder function. J Pharmacol Exp Ther 2007; 321: 642-7
3) Tyagi P et al. Mirabegron: safety review Expert Opin. Drug Safety 2011;10.2:
287-294
4) Nitti V et al. The efficacy and tolerability of mirabegron, a potent and
selective beta3-adrenoceptor agonist, compared with placebo and tolterodine slow
release in patients with overactive bladder - results from a North American Phase III
trial. Presented at ICS 2011.
5) Khullar V et al. The efficacy and tolerability of mirabegron, a potent and
selective beta3-adrenoceptor agonist, compared with placebo and tolterodine slow
release in patients with overactive bladder - results from a European-Australian Phase
III trial. Presented at ICS 2011
6) 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.
7) 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
8) Abrams P. et al. Reviewing the ICS 2002 Terminology Report: The Ongoing
Debate. Neurourol Urodyn 2006; 25: 293-294
9) Milsom I, Abrams P, Cardozo L, 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

ots Originaltext: Astellas Pharma Europe Limited
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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 , Tel: +44(0)203-379-8035, Mobile:
+44(0)7826-912-339