TGA approves Bronchitol !!!
08/Feb/2011
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.
Dr Alan Robertson, Pharmaxis Chief Executive Officer, said: “The TGA’s decision is the first approval for Bronchitol anywhere in the world and is an historic milestone for the company. It is fitting for a product that has been discovered and developed in Australia to be made available first to Australian patients. We are extremely pleased to have concluded the regulatory review process for Bronchitol with the TGA, one of the world’s leading regulatory bodies. This approval is a testament to the hard work of many people in Pharmaxis and those in the CF community worldwide who have assisted in the clinical development of Bronchitol.”
Bronchitol has been the subject of two pivotal clinical trials in cystic fibrosis in over 600 people involving 93 hospitals around the world. In April 2009 Bronchitol was awarded Orphan Drug designation in Australia for the treatment of patients with cystic fibrosis to improve lung function and reduce exacerbations.
Bronchitol has received Orphan Drug Designation and fast track status from the US Food and
Drug Administration and Orphan Drug Designation from the European Medicines Agency.
The media release is available on the Pharmaxis website.
