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Xyzal

Generic name: levocetirizine dihydrochloride
Treatment for: Allergic Rhinitis, Allergic Urticaria

Update: Xyzal Now FDA Approved - May 25, 2007

UCB, Inc. Submits New Drug Application to FDA for Xyzal

Xyzal (levocetirizine dihydrochloride) has shown efficacy in treating a variety of allergies, meaning it could represent a new option for physicians who treat allergy sufferers.

ATLANTA, July 27, 2006 -- 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 (levocetirizine dihydrochloride), a new prescription antihistamine for treatment of allergy symptoms.

If approved, Xyzal will offer U.S. physicians who treat allergy patients a new option to control their allergy symptoms. Xyzal 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 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, 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

UCB recently submitted a New Drug Application (NDA) for Xyzal (levocetirizine dihydrochloride), which UCB believes demonstrates safety and effectiveness as supported by clinical trials. Xyzal 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 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 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.1

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.

Reference:
1. http://www.aaaai.org/media/resources/media_kit/allergy_statistics.stm American Academy of Allergy, Asthma & Immunology, site accessed on July 24, 2006

For more information, please visit UCB, Inc.

Posted: July 2006

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