The European Commission has granted marketing authorization for Pharmaxis' Bronchitol as an add on therapy to cystic fibrosis (CF).
The company developed Bronchitol to aid clear the airways of CF patients.
Pharmaxis CEO Alan Robertson said that patients living with cystic fibrosis in Europe will now be able to receive the proven clinical benefits of Bronchitol.
The product showed improvement in mucus clearance, lung function compared to control, when subjects were treated for six months in two large Phase III trials.
"Pharmaxis has now secured three drug approvals in the world's largest pharmaceutical markets: the lung function test Aridol in Europe and the US and now approval for Bronchitol in Europe and Australia," Robertson said.
Source:
http://regulatoryaffairs.pharmaceutical-business-review.com/news/pharmaxis-gains-marketing-approval-for-cystic-fibrosis-therapy-in-europe-300412
