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05-02-2008, 04:07 PM
European Commission Approves Label Change For Aerius(R) (Desloratadine) For Urticaria As Well As Idiopathic Urticaria



Schering-Plough Corporation announced that the European Commission (EC) has adopted a Decision approving an extension of one therapeutic indication of AERIUS® (desloratadine) for the current European Union (EU) 27 member states as well as Iceland and Norway. The Commission Decision broadened the indications for AERIUS to cover not only "chronic idiopathic urticaria" but "urticaria", a general term meaning hives. AERIUS now has one of the broadest antihistamine labels in the EU. The new, broader indication of "urticaria" encompasses urticarial diseases such as acute urticaria, cold-induced urticaria, demographic urticaria, solar-induced urticaria and histamine release in urticaria, in addition to the prior indication of chronic idiopathic urticaria (CIU) or hives of unknown origin. Appropriate revisions are now included in the Therapeutic Indications section (4.1) and the Pharmacodynamic Properties section (5.1) of the AERIUS Summary of Product Characteristics (SPC).

The updated AERIUS label is consistent with accepted guidelines from the European Academy of Allergology and Clinical Immunology (EAACI) Dermatology Section and the Global Allergy and Asthma European Network (GA2LEN), which confirm "urticaria" as the accepted terminology for classification and recommend nonsedating antihistamines as first line treatment for urticaria.1,2

"As a physician, it is very important to have a nonsedating antihistamine, like AERIUS, indicated for the treatment of all types of urticaria according to our guidelines," said Torsten Zuberbier, M.D., Professor of Dermatology and Allergy, University of Berlin.

In two placebo-controlled six week trials studying CIU - hives of unknown cause - as a model for urticarial conditions, AERIUS was effective in relieving pruritus and decreasing the size and number of hives by the end of the first dosing interval. In each trial, the effects were sustained over the 24-hour dosing interval. An improvement in pruritus of more than 50 percent was observed in 55 percent of patients treated with desloratadine compared with 19 percent of patients treated with placebo. Treatment with AERIUS also significantly reduced interference with sleep and daytime function, as measured by a four-point scale used to assess these variables.

About Urticaria

Hives, or urticaria, are red, itchy, swollen areas of the skin (wheals) that can vary in size from about 5 mm (0.2 inches) in diameter to 25 cm (10 inches) and appear anywhere on the body. These wheals are caused by a chemical in the body called histamine which is released from certain cells.3 An episode of hives can start as itching, followed by swollen, red wheals. The itching may be mild or severe. Scratching, alcohol beverages, exercise, and emotional stress may worsen the itching.4 In the EU, as many as 32 percent of allergy sufferers report urticaria among their most prevalent allergy symptoms.5

About AERIUS

AERIUS (desloratadine) is a nonsedating antihistamine and is indicated in the EU for the treatment of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria, or hives. AERIUS Tablets, Orodispersible Tablets 5 mg and Oral Lyophilisate are approved to treat these symptoms in patients 12 years of age and older. AERIUS Orodispersible Tablets 2.5 mg are approved to treat these symptoms in patients 6 years of age and older.6 AERIUS Syrup and AERIUS Oral Solution are both approved to treat these symptoms in patients 1 year of age and older.6

The most common side effects in adults and adolescents with allergic rhinitis and CIU were fatigue, dry mouth and headache.6 In clinical trials in a pediatric population (children aged 6 months through 11 years), the overall incidence of adverse events in children 2 through 11 years of age was similar for the AERIUS syrup and placebo groups.6 In infants and toddlers aged 6 to 23 months, the most frequent adverse events reported in excess of placebo were diarrhea, fever and insomnia.6

Research shows AERIUS provides powerful morning symptom relief for seasonal allergic rhinitis patients. In a study of 346 people with moderate-to-severe seasonal allergic rhinitis, patients receiving AERIUS experienced significant improvement in morning total symptom scores (which includes both nasal and non-nasal symptoms) versus placebo.7 AERIUS offers demonstrated efficacy at the end of the dosing interval.6

Schering-Plough markets desloratadine as prescription medicines under the brand names AERIUS, AZOMYR and NEOCLARITYN in Europe and CLARINEX (http://www.medilexicon.com/drugs/clarinex.php)® in the United States. AERIUS [AZOMYR] [NEOCLARITYN] [CLARINEX] builds upon Schering-Plough's heritage as a leader in discovery and development.

About Schering-Plough Corporation

Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. In November 2007, Schering-Plough acquired Organon BioSciences, with its Organon human health and Intervet animal health businesses, marking a pivotal step in the company's ongoing transformation. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com (http://www.schering-plough.com/).

SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to AERIUS. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part I, Item IA. "Risk Factors" in Schering-Plough's 2007 10-K/A.

References:

1. Zuberbier T, Bindslev-Jensen C, Canonica W, et al. Review article: EAACI/GA2LEN/EDF guideline: definition, classification and diagnosis of urticaria. Allergy. 2006; 61: 316-320.

2. Zuberbier T, Bindslev-Jensen C, Canonica W, et al. Review article: EAACI/GA2LEN/EDF guideline: management of urticaria. Allergy. 2006; 61: 321-331.

3. American Academy of Allergy, Asthma and Immunology. Allergic Conditions: Urticaria. (http://www.aaaai.org/patients/allergic_conditions/urticaria.stm). Accessed November 15, 2007.

4. American College of Allergy, Asthma and Immunology. Urticaria. (http://www.acaai.org/public/advice/urtic.htm). Accessed November 15, 2007.

5. "Understanding the Dynamics Surrounding Allergy Suffering and Treatment" Forbes Consulting Group. 2005.

6. AERIUS [NEOCLARITYN] (summary of product characteristics). Schering Corporation.

7. Meltzer EO, Prenner MB, Nayak A, and the Desloratadine Study Group. Efficacy and tolerability of once-daily 5mg desloratadine, and H1-receptor antagonist, in patients with seasonal allergic rhinitis: assessment during the spring and fall allergy seasons. Clin Drug Invest. 2001; 21:25-32.

Schering-Plough Corporation (http://www.schering-plough.com/)