Xyzal®* Is The First And Only Antihistamine Licensed For Persistent Allergic Rhinitis

Brussels, December, 23rd 2004 - Xyzal (levocetirizine) is the first antihistamine to receive an approval for the treatment of Persistent Allergic Rhinitis (PER), in the fifteen member states making up the old EU and Norway. This approval reflects the new classification of allergic rhinitis as detailed in the Allergic Rhinitis and Its Impact on Asthma (ARIA) guidelines1 and recognises the efficacy of Xyzal in treating PER as proven in the results of the recently published XPERT study.²

This new indication was granted as a result of the XPERT study, a unique study demonstrating both the efficacy of Xyzal on symptoms and significant improvements in the quality of life of the patients. In addition, Xyzal was shown to decrease the overall costs to society of the disease and its comorbidities over the six-month treatment period. Xyzal is the first and only antihistamine to receive approval for six months continuous treatment.

PER is classified as: symptoms that are present for at least four days per week, and last at least four consecutive weeks. This indication acknowledges the potential severity of allergic rhinitis and that Xyzal presents an effective treatment for those who experience chronic and debilitating allergy symptoms.

Roch Doliveux, CEO of UCB Pharma, stated: “Xyzal is a potent antihistamine which is the only antiallergic to be approved for the treatment of PER. The approval of Xyzal in this new indication demonstrates UCB's commitment to allergy research and our determination to continue improving the treatment of allergy. We will continue to work with all physicians, regulators and patients to contain the severe symptoms of allergic diseases, which have a massive impact in terms of cost, morbidity, quality of life and loss of productivity.”

Mutual recognition has been achieved and changes to the Xyzal SmPC will be seen in the fifteen member countries and Norway over the coming months.

*Xyzal is a registered trademark of the UCB Group. Please consult your national product information as the trademark as well as the prescribing information may differ from one country to the other.

• The XPERT trial was a 6-month clinical study in 551 patients (including 278 levocetirizine-treated patients) suffering from persistent allergic rhinitis and sensitized to house dust mites and grass pollen, which demonstrated that levocetirizine 5 mg was clinically and statistically significantly more potent than placebo on the relief from the total symptom score of allergic rhinitis throughout the whole duration of the study. During the whole duration of the study, levocetirizine significantly improved the quality of life of the patients. The XPERT study also demonstrated a decrease in the overall costs of the disease on society.²
• Allergic rhinitis is a common inflammatory condition of the upper airways induced by exposure of the nasal membranes to allergens. It is characterised by symptoms such as itchy and runny nose, watery and itching eyes, sneezing and nasal congestion. Allergic rhinitis has a significant impact on quality of life ^3,4,5 and is frequently associated with other pathological conditions such as asthma.^6,7,8 It is estimated to affect 10-30% of adults and 40% children. ^9,10
• In Europe, Xyzal is one of the most recent antihistamines indicated for the treatment of allergic rhinitis and chronic idiopathic urticaria in adults and children over six years (please consult your national product information as the trademark as well as the prescribing information may differ from one country to the other). Xyzal is available as a 5mg tablet. Xyzal has been shown to produce a significant effect on the reduction of allergic rhinitis symptoms ^11,12,13 including nasal congestion.^11,12 In addition, in Switzerland and Germany, Xyzal drops are indicated for seasonal allergic rhinitis in children over two years.

For further information please visit www.ucb-group.com and www.ucbpharma.com

References

1. ARIA Bousquet J, van Cauwenberge P, Khaltaev N. ARIA Workshop Group; World Health Organization. Allergic rhinitis and its impact on asthma. J Allergy Clin Immunol 2001 Nov; 108(5 Suppl):S147-334.
2. Bachert C, Bousquet J, Canonica GW et al. Levocetirizine improves quality-of-life and reduces costs in long term treatment of Persistent Allergic Rhinitis. J Allergy Clin Immunol 2004 Oct; 114 (4).
3. Juniper EF, Guyatt GH. Development and testing of a new measure of health status for clinical trials in rhinoconjunctivitis. Clin Exp Allergy 1991; 21:77-83.
4. Kremer B, Klimek L, Bullinger M et al. Generic or disease specific quality of life scales to characterise health status in allergic rhinitis? Allergy 2001; 56:957-963.
5. Bousquet J, Bullinger M, Fayol C et al. Assessment of quality of life in patient with perennial allergic rhinitis with the French version of the SF-36 Health Status Questionnaire. J Allergy Clin Immunol 1994; 94:182-188.
6. Leynaert B, Neukirch F, Demoly P et al. Epidemiologic evidence for asthma and rhinitis co-morbidity. J Allergy Clin Immunol 2000; 106:S201-S205.
7. Leynaert B, Bousquet J, Neukirch C et al. Perennial rhinitis: an independent risk factor for asthma in nonatopic subjects: results from the European Community Respiratory Health survey. J Allergy Clin Immunol 1999; 104:301-304.
8. Lundback B. Epidemiology of rhinitis and asthma. Clin Exp Allergy 1998; 28 Suppl 2:3-10.
9. Wright AL, Holberg CJ, Martinez FD et al. Epidemiology of physician-diagnosed allergic rhinitis in childhood. Pediatrics 1994; 94:895-901.
10. American Academy of Allergy, Asthma and Immunology. The Allergy Report, Volume Overview of Allergic Diseases; pub 2000. Milwaukee, WI.
11. Day JH, Briscoe MP, Rafeiro E, Ratz JD. Comparative clinical efficacy, onset and duration of action of levocetirizine and desloratadine for symptoms of Seasonal Allergic Rhinitis in subjects evaluated in the environmental exposure unit (EEU). Int J Clin Pract 2004; 58(2):109-118.
12. Potter PC. Levocetirizine is effective for symptom relief including nasal congestion in adolescent and adult (PAR) sensitised to house dust mites. Allergy 2003; 58:893-899.
13. Bachert C et al. XPERT™ : Levocetirizine long term treatment in patients suffering from Persistent Allergic Rhinitis. Allergy 2003; 58:77 (Abstract 239).