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Biotech / Medical : Sepracor-Looks very promising -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (4561)	10/10/2000 9:23:29 AM
From: BMcV	Respond to of 10280

let's see if this lights a fire under the FDA (in the race of bureaucratic tortises): biz.yahoo.com "Press Release SOURCE: Schering-Plough Corporation Schering-Plough Announces European Union's CPMP Recommends Approval of Desloratadine for Seasonal Allergies KENILWORTH, N.J., Oct. 10 /PRNewswire/ -- Schering-Plough Corporation (NYSE: SGP - news) today 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(TM). 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 AERIUS 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."