To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: European Committee Recommends Antihistamine, Aerius (Desloratadine), For Approval URL: http://www.pslgroup.com/dg/1E3D86.htm Doctor's Guide October 10, 2000
KENILWORTH, NJ -- October 10, 2000 -- Schering-Plough Corporation announced that the Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) has issued a positive opinion recommending approval of the nonsedating antihistamine desloratadine 5 mg as a once-daily treatment for seasonal allergic rhinitis (SAR). Upon final approval, desloratadine will be marketed within the European community primarily under the brand name Aerius™. A new chemical entity, desloratadine is a long-acting, H1 receptor antagonist, blocking the effects of histamine release in the body. The marketing application for desloratadine is based on the results of four large, double-blind clinical trials in which desloratadine proved effective in relieving symptoms associated with seasonal allergies. The CPMP opinion serves as the basis for a European Commission approval, which is typically issued in approximately three months. Commission approval of the centralized Marketing Authorization Application will result in a Marketing Authorization with unified labeling that will be valid in all 15 European Union-Member States. "The CPMP recommendation represents an important step in establishing desloratadine as a significant new advance in the treatment of seasonal allergies around the world," said Roch F. Doliveux, president, Schering-Plough International. "Upon final approval, Schering-Plough plans to move swiftly to launch Aeriust in the European Union-Member States." Seasonal allergy symptoms classically include sneezing, itching, nasal discharge, nasal congestion, ocular itching, tearing and redness and itching of the palate. Seasonal allergies affect an estimated 36 million people in the five major European countries of France, Germany, Italy, Spain and the United Kingdom. Daily seasonal allergies are responsible for significant amounts of time lost from work, school and leisure activities. The prevalence of allergic diseases continues to grow, likely due to both increased exposures and enhanced responses to allergens. In addition, there is a growing body of evidence that points to an association between allergies and even more serious conditions such as asthma. The most common treatment-related side effects with desloratadine are headache, dry mouth and fatigue. These occurred with an incidence rate similar to placebo. Marketing applications for desloratadine are currently pending in the United States for the treatment of seasonal allergies and chronic idiopathic urticaria. Related link: Schering-Plough Corporation. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.