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 symptoms.
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.
About Xyzal(R)
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.
Safety Profile
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.
About UCB
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.
Forward-Looking Statement
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: Investor Relations Jean-Christophe Donck, UCB Phone: +32.2.559.9346 E-mail: jc.donck@ucb-group.com U.S. Media Lisa Garman Anne Kirby, UCB Phone: +1.770.970.8569 Phone: +1.770.970.2706 E-mail: lisa.garman@ucb-group.comanne.kirby@ucb-group.com (i) http://www.aaaai.org/media/resources/media_kit/allergy_statistics.stm; American Academy of Allergy, Asthma & Immunology, site accessed on July 24, 2006 X301-0706
UCB, Inc.
CONTACT: Investor Relations, Jean-Christophe Donck, +32-2-559-9346,jc.donck@ucb-group.com, or U.S. Media, Lisa Garman, +1-770-970-8569,lisa.garman@ucb-group.com, or Anne Kirby, +1-770-970-2706,anne.kirby@ucb-group.com, all of UCB, Inc.
Web site: http://www.ucb-group.com/
