GSK files allergy drug with EMEA and FDA

6 August 2006

UK-based drug major GlaxoSmithKline says that it has submitted its anti-allergy drug fluticasone furoate, under the proposed trade name Avamys/Allermist, to both the European Medicines Agency and the US Food and Drug Administration. Specifically, the firm is seeking regulatory approval for the product's use in the treatment of both seasonal and perennial allergic rhinitis.

Extensive trial program shows efficacy

GSK added that the efficacy and safety of the drug has been evaluated in seven clinical trials that enrolled 2,555 adult and pediatric patients who displayed symptoms of SAR and PAR.

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