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news.Pharmaxis has announced that it will apply for Australian marketing approval of Bronchitol for patients with bronchiectasis, following a meeting with the Australian Therapeutic Goods Administration or TGA.
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Pharmaxis will submit its marketing authorization application following the conclusion of the ongoing safety component of the Phase III trial – an optional 12 month extension to determine the safety of long-term Bronchitol treatment. This component of the trial has had a high participation rate and a low withdrawal rate, and will complete mid-year. The trial demonstrated a significant improvement in the quality of life for patients treated with Bronchitol, and a significant difference in their mucus clearance.
Pharmaxis will file the marketing application during the third quarter of 2008. Bronchitol is being developed as a twice daily therapy for people with the incurable lung condition Bronchiectasis.