Setback for Pharmaxis in US
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SYDNEY, Jan 31 AAP
January 31 2013, 09:12AM
A cystic fibrosis treatment developed by Australian pharmaceutical company Pharmaxis has received a negative review from advisers to regulators in the United States.
An independent expert advisory panel to the US Food and Drug Administration (FDA) voted negatively on all three areas of a review for Bronchitol, which was developed in Australia to improve pulmonary function in cystic fibrosis patients aged six and older.
"The committee vote is disappointing, however, we are aware that these recommendations are not binding on the FDA and we will continue the process of working with the FDA to bring Bronchitol to patients in the US," Pharmaxis chief executive Alan Robertson said on Thursday.
The FDA is expected to make a decision on Bronchitol on March 18.
The drug is already available to patients in Australia and Europe.
Cystic fibrosis affects about 30,000 people in the US and is the most common life-limiting genetic disease.