To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Aerius And Neoclarityn (Desloratadine) Approved In European Union for Chronic Idiopathic Urticaria URL: http://www.pslgroup.com/dg/203186.htm Doctor's Guide August 9, 2001
KENILWORTH, N.J. -- August 9, 2001 -- The European Commission of the European Union (EU) has granted marketing authorization to Schering-Plough Corporation for desloratadine 5 mg tablets as a once-daily, nonsedating treatment for the symptoms of chronic idiopathic urticaria (CIU) such as itching or hives in adults and children 12 years of age and older. Desloratadine received EU approval for the treatment of seasonal allergic rhinitis (SAR) in January 2001 and is marketed in the EU under the brand names AERIUS™ and NEOCLARITYN™.
Commission approval of the centralized application for desloratadine in CIU results in a single Marketing Authorization with unified labeling that is immediately valid in all 15 EU-Member States as well as in Iceland and Norway.
The Commission's decision follows the product's recommendation for approval in April 2001 by the EU's Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA).
"Since its EU approval in January, desloratadine has gained rapid acceptance in several major European markets as a significant new therapy for the treatment of seasonal allergies," said Roch F. Doliveux, president, Schering-Plough International. "The approval of desloratadine in the treatment of CIU represents another important step in our efforts to expand and enhance its clinical profile."
Affecting an estimated 15 to 25 percent of people at least once in their lives, urticaria is a reaction to a variety of substances, including food, drugs and topical agents, and characterized by an eruption of itchy, swollen lesions on the skin. An estimated 25 percent of urticaria patients develop CIU, which is defined as a case that lasts for a period of at least six weeks and has no identifiable cause. Up to 20 percent of prescription antihistamine use in the EU can be attributed to CIU therapy.
Desloratadine is a highly potent H-1 receptor antagonist that effectively controls the symptoms of SAR and CIU with nonsedating relief for a full 24 hours. In clinical trials the most common side effects were headache, dry mouth and fatigue, with an incidence rate similar to placebo.
SOURCE Schering-Plough Corporation
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