News
Allergic Rhinitis Treatment Avamys (fluticasone furoate) Approved in Europe
GlaxoSmithKline plc today announced that once-daily Avamys™(fluticasone furoate) nasal spray has been granted marketing authorisation by the European Commission for all 27 European member states, for the treatment of the symptoms of allergic rhinitis in adults, adolescents (12 years and older) and children (6 -- 11 years).
"Avamys is an effective new treatment for the 60 million Europeans whose working and home lives can be highly compromised by the symptoms of allergic rhinitis," stated Professor Wytske Fokkens, Chair of ENT Department, AMC, Amsterdam and Principal Investigator of the European Avamys phase III clinical trial. "Avamys has been shown in clinical trials to offer consistent and sustained relief from both the eye and nose symptoms associated with seasonal allergic rhinitis. These symptoms affect up to 70% of allergic rhinitis sufferers. For a disease where there is still high dissatisfaction with current therapies and a large amount of switching of medications, Avamys could prove to be a welcome arrival for affected patients."
This approval follows Positive Opinion from the European Medicines Agency granted in October 2007. Data presented to the European regulators included results from five randomised, double-blind, placebo-controlled phase III clinical trials involving 1,829 seasonal and perennial allergy patients 12 years of age and older.
The phase III studies show Avamys, a novel enhanced-affinity steroid, demonstrated superior efficacy to placebo in treating overall nasal allergy symptoms including congestion, sneezing, and itchy and runny nose in adults and children suffering from seasonal or year-round allergies. [1],[2],[3],[4] In addition, Avamys is the first intranasal corticosteroid spray consistently to demonstrate significant improvement in relieving overall eye symptoms associated with allergy such as red, itchy, burning and watery eyes in adult and adolescent patients with seasonal allergies.[5]