GSK announces European approval for Avamys

GlaxoSmithKline (GSK) has announced that its once-daily Avamys (fluticasone furoate) nasal spray has been granted marketing authorisation by the European Commission for the treatment of allergic rhinitis.

Avamys will soon be available in all 27 member states of the European Union and is indicated for use in adults, adolescents and children.

The approval is based on clinical trial data that was submitted to the European Medicines Agency and which received a positive opinion by the body in October 2007.

Phase III study results showed Avamys to bring significant improvements in both nose and eye symptoms caused by allergy.

Professor Wytske Fokkens, principal investigator of the European Avamys phase III trial, described the nasal spray as an “effective new treatment” for the 60 million Europeans who are affected by symptoms of allergic rhinitis.

“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,” she added.

Earlier this month, GSK and Theravance announced the launch of a series of phase IIB studies which will look to advance two compounds in the treatment of asthma.