Pharmaxis' bronchitol fast-tracked by US FDA

Australian drugmaker Pharmaxis says that the US Food and Drug Administration has granted Bronchitol (a propriety formulation of mannitol) fast-track status for the treatment of cystic fibrosis, which will accelerate the New Drug Application process, expediting its regulatory review. The FDA and European Medicines Agency (EMEA) have both previously granted the mucus-clearing agent Orphan Drug status for this life-threatening pulmonary condition.

"Phase II studies show Bronchitol significantly improves lung function and wellbeing in patients with cystic fibrosis. We look forward to working with the FDA on introducing Bronchitol to the US market as rapidly as possible," said Alan Roberts, the firm's chief executive, adding that a complete submission is expected to be ready by 2008.

The Sydney-headquartered drugmaker is conducting Phase III and II clinical trials of Bronchitol in CF patients at sites across Europe, Canada, Argentina and Australia. It is also developing the patented, inhalable dry powder drug as a treatment for bronchiectasis and chronic obstructive pulmonary diseases.