The Grazax Tablet Shows Significant Efficacy from the Very First Day of the Gras
GRAZAX? is the first tablet-based sublingual immunotherapy treatment to be developed for approval across Europe. New data demonstrate highly significant results (P>0,0001)i, with reduction in rhinoconjunctivitis symptoms (43%) and use of symptomatic medications (68%) from the very first day of the first grass pollen season with GRAZAX? treatment compared with placebo. These positive results were experienced throughout the entire treatment season, with a significant reduction in rhinoconjunctivitis symptoms (30%) (P<0,0001)i and use of symptomatic medications (38%) (P<0,0001)i. In addition, 82% of patients treated with GRAZAX? responded to the treatment, a 49% increase compared with the placebo group.
Compared with traditional symptom-relieving medications, immunotherapy is an innovative treatment that is recognised by the WHO as the only treatment to target the immunological cause of allergy, thereby altering the natural course of the disease. Use of allergen immunotherapy by injection has long been known to induce sustained symptom prevention with a potential to cure the allergic reaction to grass pollen 'C the ultimate goal of therapy 'C in patients with seasonal allergic rhinitis. Specialists have been eagerly awaiting conclusive results to confirm the place of GRAZAX? as an easily administered and convenient immunotherapy treatment that will provide a wider access to this treatment approach and more patients the opportunity of treating their allergic condition and preventing the symptoms of grass allergy:
'We are very excited by these important results from GT-08. Whilst symptomatic medications for treating the eye and nose symptoms of allergy are generally available to grass allergy sufferers everywhere, the accessibility to causal immunotherapy has been limited. The widespread variations in the availability of specialist allergy services across Europe have limited access to effective treatment for grass allergy to only very few people with many waiting in line. With GRAZAX?, we now have a treatment that can be quickly and simply administered at home by the patient', said Professor Dr Claus Bachert, the ENT Department, The University of Ghent.
GT-08 trial participants had a clinical history of grass-pollen-induced allergic rhinoconjunctivitis of two years or more, requiring treatment during the grass pollen season. The study found that the treatment dramatically reduced rhinoconjunctivitis symptoms; such as sneezing and eye and nose irritation, and, importantly, most participants considered the treatment to be convenient.
"It is encouraging to clearly demonstrate that GRAZAX? has positive effects from the beginning of the first treatment season. These results represent another important step in the process of making GRAZAX? available to grass allergic patients across Europe", said Henrik Jacobi, EVP of Research and Development at ALK-Abell'.
On March 14, 2006, the Swedish Medical Products Agency approved GRAZAX? for the treatment of grass pollen allergy. ALK-Abell' has now filed registration applications in other European countries via the mutual recognition procedure. ALK-Abell' still expects to launch GRAZAX? on the first European markets by the end of 2006 and ahead of the 2007 pollen season.
About GRAZAX? GRAZAX? is a once-daily, tablet-based sublingual immunotherapy that forms a new basis for the treatment of grass pollen allergy. It targets the underlying cause of allergy by inducing a protective immune response that reduces, and potentially cures the allergic reaction to grass pollen. GRAZAX? is a convenient treatment that is administered as a fast-dissolving sublingual (under the tongue) tablet that the patient can take at home. In this way, GRAZAX? offers new hope for the large and growing numbers of patients suffering from grass pollen allergy in Europe, as the novel route of administration makes it more convenient and easy, even in countries where specialist allergy services are lacking. About the GT-08 study
The GT-08 study is a double-blind, randomised, placebo-controlled, multi-centre phase IIIb study, designed to evaluate the clinical efficacy and safety of GRAZAX?i. Initiated in late 2004, the study comprises 634 patients allergic to grass pollen at 51 clinics in Denmark, Germany, Italy, the Netherlands, Spain, the United Kingdom, Austria and Sweden. All patients have moderate to severe allergic rhinitis, with or without asthma, and participants were randomly assigned to receive either GRAZAX? or placebo every day.i The GT-08 study will continue in years to come with a view to documenting the long-term benefits of GRAZAX?.
About ALK-Abell' ALK-Abell' is devoted to improving the lives of people with allergies by developing pharmaceutical products that target the cause of their allergic disease. ALK-Abell' is the world leader in the development of immunotherapy treatments 'C a unique treatment that induces a protective immune response with sustained symptom prevention. Allergy immunotherapy is traditionally conducted as subcutaneous injections or sublingual droplets. ALK-Abell' aims to extend the use of immunotherapy by introducing convenient tablets for home treatment, thereby offering many more patients a causal allergy treatment. ALK-Abell' has more than 1,200 employees with subsidiaries, production facilities and distributors throughout the world. The company is headquartered in H?rsholm, Denmark and listed on the Copenhagen Stock Exchange.
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