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Novartis International AG

Emselex Receives Positive CHMP Opinion for the Treatment of Overactive Bladder

Basel, Switzerland (ots/PRNewswire)

Novartis Pharma AG announced
today that the Committee for Medicinal Products for Human Use (CHMP),
adopted a positive opinion recommending that the European Commission
(EC) grant a Marketing Authorisation for Emselex(R) (darifenacin
hydrobromide), 7.5mg and 15mg, for the treatment of overactive
bladder (OAB) in all 25 European Union (EU) countries as well as
Norway and Iceland. Upon receipt of the EC approval, Novartis will be
able to market Emselex throughout these countries.
"We are delighted by the CHMP's positive opinion for Emselex, to
provide  overactive bladder sufferers with a new safe and effective
treatment option",  said Jorg Reinhardt, Global Head of Development
Novartis Pharma AG. "Due to  its M3 selectivity, Emselex provides
effective overactive bladder symptom  relief while decreasing the
potential risk of safety issues such as cognitive  impairment or
effects on cardiac function."
OAB affects almost one in six adults in Europe(1). Symptoms of
overactive bladder are urinary urgency (a sudden compelling desire to
pass urine, which is difficult to differ) with or without urge
incontinence (involuntary leakage accompanied by urgency), urinary
frequency (voiding the bladder too often), and nocturia (waking at
night one or more times to void the bladder).
The CHMP based its positive opinion on Emselex's comprehensive
data package for OAB. The safety and efficacy of Emselex has been
extensively studied in over 90 pre-clinical studies and clinical
trials, involving more than 5,000 patients. Pivotal studies explored
key endpoints including the reduction in the number of incontinence
episodes per week, the reduction in the number of voluntary urination
episodes (micturition) per day, the reduction in the episodes and
severity of urgency and an increase in the average volume of urine
passed per micturition.
The phase III clinical trials demonstrated the efficacy, safety
and tolerability of Emselex. A pooled analysis of three multicentre,
double-blind, placebo-controlled studies included a population of
1,049 adults with OAB symptoms for more than 6 months. Results
demonstrated that Emselex reduces the number of weekly incontinence
episodes by up to 77%(1). Emselex was well tolerated and
discontinuation rates due to dry mouth or constipation were very low
with each dose of Emselex compared to placebo(2). Also, central
nervous system (CNS) and cardiovascular safety of Emselex were
comparable to placebo at both doses(1). Another study showed Emselex
does not impair cognitive function such as memory, choice reaction
time and word recognition, compared to placebo(3).
About Novartis
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and
consumer health. In 2003, the Group's businesses achieved sales of
USD 24.9 billion and a net income of USD 5.0 billion. The Group
invested approximately USD 3.8 billion in R&D. Headquartered in
Basel, Switzerland, Novartis Group companies employ about 80 000
people and operate in over 140 countries around the world. For
further information please consult http://www.novartis.com.
Disclaimer
This release contains certain forward-looking statements that can
be identified by the use of forward-looking terminology, such as
"upon receipt of ... approval", "will be able to market",
"potential", "may be" or similar expressions, or by express or
implied discussions regarding potential marketing approvals or future
sales of Emselex. Such forward looking statements reflect the current
views of the Company regarding future events, and involve known and
unknown risks, uncertainties and other factors that may cause the
actual results with Emselex to be materially different from any
future results, performance, or achievements expressed or implied by
such statements. There can be no guarantee that Emselex will be
approved for sale in any new market or that it will reach any
particular sales levels. Any such commercialisation can be affected
by, amongst other things, uncertainties relating to clinical trials,
regulatory actions or delays or government regulation generally, the
ability to obtain or maintain patent or other proprietary
intellectual property protection and competition in general,
government, industry, and general public pricing pressures, as well
as factors discussed in the Company's Form 20F filed with the US
Securities and Exchange Commission. Should one or more of these risks
or uncertainties materialise, or should underlying assumptions prove
incorrect, actual results may vary materially from those described
herein as anticipated, believed, estimated or expected. Novartis is
providing the information in this press release as of this date and
does not undertake any obligation to update any forward-looking
statements contained in this press release as a result of new
information, future events or otherwise.
References
1. Milson I, Abrams P, Cardozo L, Roberts RG, Thuroff J, Wein AJ.
How widespread are the symptoms of an overactive bladder and how are
they managed? A population-based prevalence study. BJU Int
2001;87:760-6. Erratum, BJU Int 2001;88:807
2. Chapple C. Darifenacin is effective in improving the major
symptoms of overactive bladder: A pooled analysis of phase III
studies. Eur Urol Suppl 2004;3(2):A512
3. Wesnes K, Lipton R, Kolodner K, Edgar C. Darifenacin, an M3
selective receptor antagonist for the treatment of overactive
bladder, does not affect cognitive function in elderly volunteers.
Eur Urol Suppl 2004;3(2):A513

Contact:

Eric Althoff, Novartis Pharma Communications, + 41-61-324-6392
(direct) +41-79-593 4202 (mobile) eric.althoff@pharma.novartis.com
Satoshi Sugimoto, Novartis Global Media Relations, +41-61-324-6129
(direct) +41-61-324-2200 (main)
satoshi_jean.sugimoto@group.novartis.com

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