EC Sanctions Pharmaxis’ Bronchitol as Add-On Therapy for Cystic Fibrosis

Respiratory disease therapeutics firm Pharmaxis achieved EC approval for its cystic fibrosis therapy Bronchitol. It is indicated for use in helping to clear the airways of mucus as an add-on therapy to best standard of care.  Clearance across the 29 European countries was based on data from two Phase III studies, which showed that the dry powder inhaled mannitol formulation improved mucus clearance, improved lung function, and reduced infectious episodes.

Bronchitol was first granted marketing clearance in Australia in February 2011. The product is also undergoing Phase III development in patients with bronchiectasis. One study has been completed, and a second global Phase III study is evaluating the efficacy of Bronchitol for reducing infectious episodes, antibiotic use, and hospitalization time.

Australian firm Pharmaxis’ first marketed product, Aridol®/Osmohale, is an indirect osmotic bronchial challenge test kit used to aid in the diagnosis of asthma by assessing  bronchial hyperresponsiveness in children and adults. The product is approved in Australia, major European countries, South Korea, and the U.S. Pharmaxis says the test is the only Europe-wide approved lung function test, and the world's first approved indirect challenge test for asthma.