Investor Centre

A drug discovered and developed in Australia has been listed on the Pharmaceutical Benefits Scheme (PBS) for the treatment of cystic fibrosis: one of the world’s most common life-shortening genetic diseases.

Bronchitol® (mannitol) is the first of a new class of cystic fibrosis medicines designed to tackle one of the fundamental problems that leads to loss of lung function.  It has been the subject of one of the largest clinical trial programs undertaken in cystic fibrosis - conducted in over 600 patients in 10 countries around the world and co-ordinated by scientists based in Australia. 

Pharmaceutical company Pharmaxis (ASX: PXS) is pleased to announce it has received notification from the United States Food and Drug Administration (FDA) that the New Drug Application (NDA) for its cystic fibrosis product, Bronchitol®, has been accepted for standard review.

The FDA has assigned the Bronchitol application a Prescription Drug User Fee Act (PDUFA) goal date of 18 March, 2013.  If the application is approved, Pharmaxis anticipates Bronchitol could be available for US patients with cystic fibrosis in the second quarter of 2013.