Pharmaxis has received a positive opinion from the CHMP for Bronchitol to treat adults with cystic fibrosis (CF) in Europe.
The drug’s indication is to help clear mucus, improve lung function and reduce exacerbations in CF patients over the age of 18, which represents approximately two thirds of those who could benefit from the therapy.
Dr Alan Robertson, CEO of Pharmaxis, said that the positive opinion “is good news for the CF community, which has supported us throughout the development of Bronchitol”.
The treatment consists of mannitol administered as a dry powder in a hand-held inhaler and is to be used as an add-on therapy to standard medications already in use.
Professor Stuart Elborn, President of the European Cystic Fibrosis Society, said that the medication will be the first approved therapy in Europe to improve both lung function and reduce exacerbations when added to standard medications in use today.
“Life expectancy in cystic fibrosis is improving but there remains an urgent need for new therapies,” he added.
Bronchitol’s approvals in Australia and Europe are based on two Phase III clinical trials involving more than 600 CF patients.
Bronchitol was developed in Australia and will be commercialised through the EU in collaboration with the company’s marketing partner, Quintiles.
Pharmaxis plans to undertake a clinical trial in children aged 6-17, with a view to extend the drug’s licence.
Pharmaceutical company Pharmaxis researches, develops and commercialises therapeutic products for chronic respiratory disorders.