ATLANTA, July 27 /PRNewswire/ -- UCB, Inc. announced today the
submission of a New Drug Application (NDA) to the United States Food and
Drug Administration (FDA) for the approval of Xyzal(R) (levocetirizine
dihydrochloride), a new prescription antihistamine for treatment of allergy
If approved, Xyzal(R) will offer U.S. physicians who treat allergy
patients a new option to control their allergy symptoms. Xyzal(R) is
already available in many countries around the world. UCB requested as part
of the FDA application, the following indications: Seasonal Allergic
Rhinitis, Perennial Allergic Rhinitis, and Chronic Idiopathic Urticaria.
"The NDA submission for Xyzal(R) is an alternative for U.S. physicians
seeking an effective prescription treatment for patients that do not
experience relief with existing medicines," said Roch Doliveux, CEO and
chairman of UCB's Executive Committee. "UCB is committed to helping meet
unmet medical needs for patients with allergy symptoms that negatively
impact their quality of life."
"Allergic Rhinitis affects upwards of 40 million people in the United
States. Xyzal(R), when approved and available from UCB, will represent
another option for many sufferers whose allergy symptoms are uncontrolled
by current available therapies," said Dr. Sheldon Spector, an allergist and
Clinical Professor of Medicine, University of California at Los Angeles
(UCLA) School of Medicine, Los Angeles, California.
Only an allergist can properly test for the specific triggers that are
the cause of a patient's allergy symptoms. Patients with allergy symptoms
should see their allergist to identify the triggers that are affecting them
to aid in the development of an effective treatment plan.
UCB recently submitted a New Drug Application (NDA) for Xyzal(R)
(levocetirizine dihydrochloride), which UCB believes demonstrates safety
and effectiveness as supported by clinical trials. Xyzal(R) is intended for
use as a once-daily antihistamine for which UCB has requested the
indications: symptomatic treatment of Seasonal Allergic Rhinitis, Perennial
Allergic Rhinitis, and Chronic Idiopathic Urticaria in adults and children
six years of age and older.
Xyzal(R) was first launched in Europe in 2001 and is currently marketed
in 49 countries around the world.
In the U.S. application, it was reported that the most common (greater
than or equal to 2%) adverse events in patients aged 12 years and older
that occurred more frequently on Xyzal(R) than placebo were
nasopharyngitis, somnolence, fatigue, and dry mouth. In children 6 to 12
years old, pyrexia, cough, somnolence, and epistaxis were more commonly
reported. Most adverse events were considered mild to moderate.
About Allergic Conditions
Many people suffer from the symptoms associated with common allergic
conditions. The immune system of allergy sufferers over-reacts to something
in the environment. This can lead to symptoms that affect their respiratory
system, eyes, or skin. Estimates from a skin test survey suggest that
allergies affect as many as 40 to 50 million people in the United States --
more than 20 percent of the U.S. population.
Seasonal Allergic Rhinitis (SAR), commonly referred to as "hay fever"
or "outdoor allergies," is the most common form of allergic rhinitis. By
definition, SAR includes allergies to seasonal pollens like grass, trees,
fungal molds, and weeds. Perennial Allergic Rhinitis (PAR) is sometimes
referred to as "year round" or "indoor allergies" and is characterized by
allergies that last longer than four weeks. House dust mites, animal
dander, and mold most commonly trigger PAR. Chronic Idiopathic Urticaria
(CIU) is most commonly known as "hives of unknown origin" and is defined as
the occurrence of daily, or almost daily, wheals and itching for at least
six weeks with no obvious causes.
UCB (www.ucb-group.com) is a leading global biopharmaceutical company
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 8,500 people in 40 countries, UCB
achieved revenues of euro 2.3 billion in 2005. UCB is listed on the
Euronext Brussels Exchange with a market capitalization of approximately
euro 6.0 billion. Worldwide headquarters are located in Brussels, Belgium,
and U.S. headquarters are located in Atlanta, Georgia.
This news release contains forward-looking statements that involve
risks and uncertainties, including statements with respect to the safety,
efficacy and potential benefits of levocetirizine dihydrochloride, the
development and commercialization of levocetirizine dihydrochloride. Among
the factors that could cause actual results to differ materially from those
indicated by such forward-looking statements are: the results of research,
development and clinical trials; the timing and success of submission,
acceptance, and approval of regulatory filings; the time and resources UCB
devotes to the development and commercialization of levocetirizine
dihydrochloride and the scope of UCB's patents and the patents of others.
In addition, the statements in this press release represent UCB's
expectations and beliefs as of the date of this press release. UCB
anticipates that subsequent events and developments may cause these
expectations and beliefs to change. However, while UCB may elect to update
these forward-looking statements at some point in the future, it
specifically disclaims any obligation to do so. These forward-looking
statements should not be relied upon as representing UCB's expectations or
beliefs as of any date subsequent to the date of this press release.
Inquiries, please contact:
Jean-Christophe Donck, UCB
Lisa Garman Anne Kirby, UCB
Phone: +1.770.970.8569 Phone: +1.770.970.2706
E-mail: firstname.lastname@example.org email@example.com
American Academy of Allergy, Asthma & Immunology, site accessed on
July 24, 2006
SOURCE UCB, Inc.