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Allermist

Treatment for Allergic Rhinitis

New Seasonal and Perennial Rhinitis Intranasal Treatment Submitted for U.S. and European Marketing Approval

Allermist / Avamys (fluticasone furoate) Significantly Improved Symptoms of Seasonal and Perennial Allergic Rhinitis in Clinical Studies

RESEARCH TRIANGLE PARK, N.C., July 27, 2006 -- GlaxoSmithKline (GSK) today announced it has submitted applications for both U.S. and European marketing approval for a new medicine to treat the symptoms of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). The medicine (fluticasone furoate) is an enhanced affinity intranasal corticosteroid with the proposed name of Allermist in the U.S. and Avamys in Europe.

The efficacy and safety of Allermist / Avamys have been evaluated in seven clinical trials with 2,555 adult and pediatric patients two years of age and older with symptoms of SAR and PAR. Patients taking the medicine reported significant improvements in a range of nasal symptoms compared to those taking a placebo. In adult patients with SAR, in addition to nasal symptom improvement, Allermist / Avamys use was also consistently associated with significant improvement in ocular symptoms such as watery, itchy eyes.

"This is an important milestone in our respiratory research and we hope this medicine will offer help to millions of seasonal and perennial allergy patients," said Kathy Rickard, M.D., Vice President Clinical, Respiratory Medicine Development Center (North America).

Developed after ergonomic testing, Allermist / Avamys is dispensed using a novel nasal device, designed with the patient in mind. There is minimal or no aftertaste with Allermist / Avamys and the product is unscented and alcohol- free.

About Allergic Rhinitis

Allergic rhinitis is an inflammatory disease characterized by the symptoms of runny nose (rhinorrhea), nasal congestion, watery eyes, sneezing and itching of the nose and ocular symptoms of red, itching/burning and watery eyes. Symptoms occur after exposure to allergens such as mold spores and pollens which cause SAR, or to year-round allergens such as dust mites or animal dander which cause PAR.

One of the most prevalent and chronic diseases in the U.S., allergic rhinitis affects up to 40 million people annually, including 10 to 30% of adults and up to 40% of children. In Europe, more than 1 in 5 adults are estimated to suffer from allergic rhinitis, of which nearly half are undiagnosed.

Allergic rhinitis can limit productivity, resulting in both work absenteeism and reductions in effectiveness among adult patients. In children, allergic rhinitis can significantly reduce energy, negatively affect behavior, and impair learning.

Source: GlaxoSmithKline

Posted: July 2006

Allermist (fluticasone furoate) FDA Approval History

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