EU gives marketing approval for Bronchitol (Pharmaxis ) to treat Cystic Fibrosis

The EU has given marketing authorisation for Bronchitol (inhaled dry powder mannitol), from Pharmaxis, for Cystic Fibrosis patients. The licence allows the new Cystic Fibrosis treatment to be made available for patients aged 18 and above as an add-on therapy to the best standard of care in 29 European countries. Patients in Germany and the UK, where there is less requirement for pricing and reimbursement approval before launch, will be first to get access to Bronchitol. These two countries make up 40% of the European market by value. Pharmaxis expects stock to be available for sale in Europe by June 1st ahead of the official launch of the product, which will take place at the European Cystic Fibrosis Conference in Dublin from 6th - 9th June 2012. Approval is based on two large Phase III clinical trials, in which Bronchitol improved mucus clearance, improved lung function and reduced infectious episodes compared to control when patients were treated for 6 months.