Pharmaxis drug earns FDA 'orphan' status for cystic fibrosis
Wednesday, 20 July, 2005
The US Food and Drug Administration has expanded an 'orphan drug' designation to Pharmaxis' (ASX:PXS) drug Bronchitol, for the additional indication of facilitating mucus clearance in patients with cystic fibrosis.
Pharmaxis was initially granted orphan drug status for Bronchitol as a treatment for patients with bronchiectasis in February.
Orphan drug status is granted to treatment aimed at serious or life-threatening diseases. Cystic fibrosis patients have a defective gene which causes the body to produce an abnormally thick, sticky mucus that clogs the lungs and leads to life-threatening lung infections.
"There have been no therapeutic advances to help clear congested lungs for patients with cystic fibrosis in the past 10 years," said Pharmaxis CEO Alan Robertson in a statement.
Under orphan drug status, Pharmaxis has a seven-year period of market exclusivity. Other incentives include assistance from the FDA with clinical trial design and an exemption from FDA user fees.
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