Neupro® recommended for approval in Europe for Restless Legs Syndrome
Brussels, Belgium, 25 April, 2008 at 8:00 am CET - UCB today
announced that the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMEA) has issued a positive
opinion recommending that the European Commission grants a marketing
authorisation for Neupro® (rotigotine transdermal patch) in the
symptomatic treatment of moderate-to-severe idiopathic Restless Legs
Syndrome (RLS) in adults.
The CHMP decision is based on data from two well-controlled clinical
trials that evaluated the efficacy and safety of Neupro® over a six
month period in almost 1,000 patients with RLS. In these trials,
Neupro® showed significant and clinically relevant improvements in
RLS symptoms compared to placebo and was generally well tolerated.
"The CHMP recommendation is encouraging news and we are hopeful that
the European Commission will act favourably on the marketing
authorization for Restless legs syndrome. We will be filing a
Restless legs syndrome manufacturing variation with the EMEA. We are
looking forward to making Neupro® available as a new therapeutic
option to people living with this chronic neurological disorder",
said Troy Cox, President CNS Operations, UCB.
Restless Legs Syndrome affects between 3 and 10% of the population,
causing unpleasant sensations such as tingling, burning, tugging,
gnawing and pulling in the legs. Symptoms frequently occur during
periods of rest and inactivity such as during long flights and car
trips, or at night.
"Restless Legs Syndrome can have a significant impact on the everyday
lives of patients, disrupting their working and leisure activities
and disturbing their rest and sleep", said Professor Claudia
Trenkwalder, Paracelsus-Elena Klinik, Kassel and University of
Goettingen, Germany. "In clinical trials, over a six month period,
rotigotine provided clinical improvement to patients negatively
impacted by the symptoms of Restless Legs Syndrome. A further new
treatment would be a welcome option for patients and physicians."
Neupro® is approved in Europe for the treatment of the signs and
symptoms of early-stage idiopathic Parkinson's disease as monotherapy
and as adjunctive therapy with levodopa for advanced-stage
Key study results
The data supporting the licence application is based on the results
of two fixed-dose, randomized, double-blind, placebo-controlled
efficacy and safety studies that evaluated rotigotine for the
treatment of moderate-to-severe idiopathic RLS in almost 1 000
patients from EU and US over six months.
The efficacy of rotigotine (0.5-3 mg/ 24 hours) was evaluated by
using the International Restless Legs Severity Scale (IRLS), a
clinician-administered tool considered to be the best scale for
evaluating the severity and frequency of RLS symptoms and the degree
to which they affect sleep and daily life. Additionally the change in
the severity of illness was evaluated by monitoring the Clinical
Global Impressions (CGI) Item 1 scores.
In both studies, rotigotine (2 mg/ 24 hours and 3 mg/ 24 hours) was
shown to have a statistically significant and clinically relevant
improvement in the IRLS sum scores and a reduction in the CGI-1 score
compared to placebo, with sustained improvement observed throughout
the six-month maintenance phase.
The most frequently reported adverse events associated with
rotigotine in these studies were application site reactions, nausea,
dizziness, somnolence and headache.
About Restless Legs Syndrome: Restless legs syndrome (RLS) is a
chronic neurological disorder that affects between 3 and 10% of the
population to some extent. It is characterized by unpleasant feelings
in the legs and an irresistible urge to move in order to relieve the
discomfort. RLS sensations are frequently described as tingling,
burning, tugging, gnawing and pulling. The exact cause of RLS is not
known; however, recent clinical research has linked certain genes to
RLS, suggesting that the disorder is genetically based.
Symptoms of RLS typically appear during periods of rest and
inactivity, particularly in the evenings and at night. This can make
it difficult to fall asleep and stay asleep, thus preventing
recuperative sleep and often leading to daytime fatigue and reduced
alertness. While RLS symptoms are generally most pronounced in the
evening and while at rest, other periods of inactivity, such as long
flights, car trips and sitting in a theatre or cinema, can also
About Neupro® in Europe: In Europe, Neupro® is indicated for the
treatment of the signs and symptoms of early-stage idiopathic
Parkinson's disease as monotherapy and in combination with levodopa
for advanced stage Parkinson's disease.
Important Safety Information
Neupro® has been associated with somnolence and episodes of sudden
sleep onset, particularly in patients with Parkinson's disease.
Sudden onset of sleep during daily activities in some cases without
awareness of any warning signs, has been reported. Pathologic
gambling, increased libido and hypersexuality have been reported in
patients treated with dopamine agonists for Parkinson's disease,
It is recommended to monitor blood pressure, especially at the
beginning of treatment, due to the general risk of orthostatic
hypotension associated with dopaminergic therapy.
Hallucinations have been reported and patients should be warned that
hallucinations can occur.
Caution is advised when treating patients with severe hepatic
impairment which may result in lower rotigotine clearance.
Adverse drug reactions reported in more than 10% of patients treated
with Neupro® transdermal patch are nausea, dizziness, somnolence and
application site reactions. Application site reactions are usually
mild or moderate in intensity and it is recommended that the
application site should be rotated on a daily basis.
Neupro® is a registered trademark and is distributed by Schwarz
Pharma, a company of UCB Group.
UCB (Brussels, Belgium) (www.ucb-group.com) is a global leader in the
biopharmaceutical industry dedicated to the research, development and
commercialization of innovative pharmaceutical and biotechnology
products in the fields of central nervous system disorders,
allergy/respiratory diseases, immune and inflammatory disorders and
oncology. UCB focuses on securing a leading position in severe
disease categories. Employing around 12 000 people in over 40
countries, UCB achieved revenue of 3.6 billion euro in 2007. UCB S.A.
is listed on Euronext Brussels.
Antje Witte, Vice-President Corporate Communications & Investor
Relations, UCB Group
T +32.2.559.9414, Antje.firstname.lastname@example.org
Forward looking statement
This press release contains forward-looking statements based on
current plans, estimates and beliefs of management. Such statements
are subject to risks and uncertainties that may cause actual results
to be materially different from those that may be implied by such
forward-looking statements contained in this press release. Important
factors that could result in such differences include: changes in
general economic, business and competitive conditions, effects of
future judicial decisions, changes in regulation, exchange rate
fluctuations and hiring and retention of its employees.
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