FDA fast-tracks Pharmaxis cystic fibrosis drug

The FDA fast-tracks the new drug application process if a therapy can potentially address an unmet medical need for a life-threatening disease. Designation as a fast track product is designed to expedite regulatory review of drugs. The FDA and the European Medicines Agency have both previously granted Bronchitol orphan drug status for treating cystic fibrosis.

“Phase II studies show Bronchitol significantly improves lung function and wellbeing in patients with cystic fibrosis,” said Pharmaxis CEO Dr Alan Robertson.

There have been no treatment advances in cystic fibrosis in over a decade, and no products are approved to improve lung hydration. A recent report showed that existing treatments for cystic fibrosis such as Genentech’s Pulmozyme and Tobramycin do not improve lung function in patients. Pharmaxis is developing Bronchitol as a treatment to improve mucus clearance in the lungs of patients with cystic fibrosis, bronchiectasis and pulmonary diseases.

Pharmaxis is currently conducting phase III and II clinical trials of Bronchitol in cystic fibrosis patients at sites in Europe, Canada, Argentina and Australia.