For the latest media releases and news about Pharmaxis Ltd, please select from the following articles. Material news announcements made by Pharmaxis are first filed with the Australian Securities Exchange (ASX) and are also available on the ASX website.
Pharmaxis today announced that the Australian Therapeutic Goods Administration (TGA) has approved Bronchitol (inhaled dry powder mannitol) for marketing in Australia for the treatment of cystic fibrosis and it is now to be included in the Australian Register of Therapeutic Goods (ARTG).
Bronchitol has been approved for the treatment of cystic fibrosis (CF) in both adult and paediatric patients aged over six years as either an add-on therapy to dornase alfa or in patients intolerant of, or inadequately responsive to, dornase alfa.Read full media release - pdf
Pharmaxis made an oral presentation to last week's meeting of the European Committee for Medicinal Products for Human Use (CHMP). Subsequent to the meeting the CHMP has now provided the company with its outstanding issues and advised that the review timetable will conclude in Q2 2011.
“We are pleased with the ongoing discussions with the CHMP and believe we are in a good position to provide our response to their outstanding issues in a timely manner", said Dr Alan Robertson, Chief Executive Officer of Pharmaxis.
Bronchitol has been the subject of two international Phase 3 clinical trials and is the only new product in registration to treat cystic fibrosis.Read full media release - pdf