FDA Approves Xyzal (levocetirizine dihydrochloride) Oral Solutionfor the Relief of Seasonal and Year Round Allergies and ChronicIdiopathic Urticaria
BRUSSELS, Belgium and PARIS, February 19, 2008 at 8:00 am CET - UCB and sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) approved a New Drug Application (NDA) for Xyzal (levocetirizine dihydrochloride) 0.5 mg/mL oral solution, a prescription antihistamine indicated for the relief of symptoms associated with indoor and outdoor allergies, as well as the treatment of chronic idiopathic urticaria. Xyzal tablets received FDA approval on May 25, 2007 and both formulations are now approved for use in adults and children 6 years and older.
"The oral solution of Xyzal provides a welcome alternative for those patients who have difficulty swallowing or who prefer liquid medication," said Michael S. Blaiss, MD, Clinical Professor of Pediatrics and Medicine at the University of Tennessee Health Science Center in Memphis, Tennessee. "Both the oral solution and tablets offer patients powerful and long-lasting allergy relief."
Studies in allergic rhinitis patients demonstrated levocetirizine significantly reduced the symptoms of sneezing, itchy nose, runny nose, and itchy eyes. Studies in chronic idiopathic urticaria patients showed levocetirizine significantly reduced the severity of itching and the number and size of wheals.
In September 2006, UCB and sanofi-aventis entered into an agreement to launch and co-market Xyzal in the U.S. UCB and sanofi-aventis have a long history in the allergy treatment arena and are committed to advancing treatment for allergy sufferers and helping meet unmet medical needs for patients with chronic allergy symptoms.
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, leading to symptoms that affect their respiratory system, eyes, or skin. Estimates from the American Academy of Allergy, Asthma & Immunology (AAAAI) suggest that indoor and outdoor allergies affect as many as 40 million people in the United States.
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, and weeds, as well as mold. Perennial Allergic Rhinitis (PAR) is sometimes referred to as "year round" or "indoor allergies" and is characterized by allergic symptoms 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 "chronic 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 Xyzal
Indications and Important Safety Information
Xyzal is indicated for the relief of symptoms associated with allergic rhinitis (seasonal and perennial) and the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.
The use of Xyzal is contraindicated in: patients with a known hypersensitivity to levocetirizine or any of the ingredients of Xyzal or to cetirizine (observed reactions range from urticaria to anaphylaxis); patients with end-stage renal impairment at less than 10 mL/min creatinine clearance or patients undergoing hemodialysis; and pediatric patients aged 6 to 11 years with impaired renal function.
Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination, such as operating machinery or driving a motor vehicle, after ingestion of Xyzal. Concurrent use of Xyzal with alcohol or other central nervous system (CNS) depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur.
In clinical trials, the most common adverse reactions in >=2% of adult and adolescent patients (12 years of age and older) taking Xyzal 2.5 mg, Xyzal 5 mg, or placebo were somnolence (5%, 6%, 2%), nasopharyngitis (6%, 4%, 3%), fatigue (1%, 4%, 2%), dry mouth (3%, 2%, 1%), and pharyngitis (2%, 1%, 1%), respectively.
In clinical trials 4 to 6 weeks in duration, the most common adverse reactions in > 2% of pediatric patients (6-12 years of age) taking Xyzal 5 mg included pyrexia (4% vs 2% placebo), cough (3% vs <1% placebo), somnolence (3% vs <1% placebo) and epistaxis (2% vs <1% placebo).
About UCB
UCB, Brussels, Belgium is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialisation 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 3.5 billion euro in 2006 on a pro forma basis. UCB S.A. is listed on Euronext Brussels. SCHWARZ PHARMA AG (Monheim, Germany) is a member of the UCB Group.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
UCB Forward-Looking Statement
This news release contains
forward-looking statements that involve risks and uncertainties,
including statements with respect to the development and
commercialization of levocetirizine. 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 and the scope of UCB's patents
and the patents of others.
Sanofi-aventis Forward-Looking Statements
This press release
contains forward-looking statements as defined in the Private
Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical
facts. These statements include product development, product
potential projections and estimates and their underlying
assumptions, statements regarding plans, objectives, intentions and
expectations with respect to future events, operations, products
and services, and statements regarding future performance.
Forward-looking statements are generally identified by the words
"expects," "anticipates," "believes," "intends," "estimates,"
"plans" and similar expressions. Although sanofi-aventis'
management believes that the expectations reflected in such
forward-looking statements are reasonable, investors are cautioned
that forward-looking information and statements are subject to
various risks and uncertainties, many of which are difficult to
predict and generally beyond the control of sanofi-aventis, that
could cause actual results and developments to differ materially
from those expressed in, or implied or projected by, the
forward-looking information and statements. These risks and
uncertainties include among other things, the uncertainties
inherent in research and development, future clinical data and
analysis, including post marketing, decisions by regulatory
authorities, such as the FDA or the EMEA, regarding whether and
when to approve any drug, device or biological application that may
be filed for any such product candidates as well as their decisions
regarding labeling and other matters that could affect the
availability or commercial potential of such products candidates,
the absence of guarantee that the products candidates if approved
will be commercially successful, the future approval and commercial
success of therapeutic alternatives as well as those discussed or
identified in the public filings with the SEC and the AMF made by
sanofi-aventis, including those listed under "Risk Factors" and
"Cautionary Statement Regarding Forward-Looking Statements" in
sanofi-aventis' annual report on Form 20-F for the year ended
December 31, 2006. Other than as required by applicable law,
sanofi-aventis does not undertake any obligation to update or
revise any forward-looking information or statements.
Posted: February 2008
Related articles
- Sanofi's Xyzal Allergy 24HR Approved for Over-the-Counter Use - February 1, 2017
- FDA Approves Xyzal For Use In Children Age Six Months And Older For The Relief Of Perennial Allergic Rhinitis And Chronic Idiopathic Urticaria - August 25, 2009
- FDA Approves Xyzal (Levocetirizine Dihydrochloride) Tablets for theRelief of Seasonal and Year Round Allergies, and Chronic Hives - May 29, 2007
- UCB, Inc. Submits New Drug Application to FDA for Xyzal - July 27, 2006
Xyzal (levocetirizine dihydrochloride) FDA Approval History
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