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US FDA Grants Pharmaxis' Bronchitol Orphan Drug Status
23 / 02 / 2005
Pharmaxis (ASX:PXS) announced today that the United States Food and Drug Administration (FDA) has granted an Orphan Drug status for the company's product BronchitolT, for the treatment of bronchiectasis.
Orphan drug status has been granted to Pharmaxis on the basis of Bronchitol's ability to aid the treatment of bronchiectasis, an incurable, degenerative and chronic inflammatory condition of the lungs affecting over half a million people worldwide.
Orphan drug status is granted by the US FDA to those products intended for the diagnosis, prevention and treatment of rare diseases, or conditions where no current therapy exists or would be improved. Orphan drug status entitles Pharmaxis to a range of incentives including a seven-year period of market exclusivity and study design assistance that will substantially contribute to rapid approval.
Alan Robertson, Pharmaxis chief executive officer said: "We are extremely pleased that Bronchitol has been granted Orphan Drug status by the FDA. With these concessions Bronchitol will proceed more quickly towards the international trials required for approval, and patients will receive benefits sooner."
In late 2004, Pharmaxis reported positive results from a two week Bronchitol study in patients with bronchiectasis. Most cases of bronchiectasis develop during childhood, some rare cases are present from birth. Bronchiectasis can be the result of infections such as pneumonia or the inhalation of irritating substances, causing inflammation of the bronchial wall.
To find out more about Pharmaxis, go to http://www.pharmaxis.com.au.
Orphan drug status has been granted to Pharmaxis on the basis of Bronchitol's ability to aid the treatment of bronchiectasis, an incurable, degenerative and chronic inflammatory condition of the lungs affecting over half a million people worldwide.
Orphan drug status is granted by the US FDA to those products intended for the diagnosis, prevention and treatment of rare diseases, or conditions where no current therapy exists or would be improved. Orphan drug status entitles Pharmaxis to a range of incentives including a seven-year period of market exclusivity and study design assistance that will substantially contribute to rapid approval.
Alan Robertson, Pharmaxis chief executive officer said: "We are extremely pleased that Bronchitol has been granted Orphan Drug status by the FDA. With these concessions Bronchitol will proceed more quickly towards the international trials required for approval, and patients will receive benefits sooner."
In late 2004, Pharmaxis reported positive results from a two week Bronchitol study in patients with bronchiectasis. Most cases of bronchiectasis develop during childhood, some rare cases are present from birth. Bronchiectasis can be the result of infections such as pneumonia or the inhalation of irritating substances, causing inflammation of the bronchial wall.
To find out more about Pharmaxis, go to http://www.pharmaxis.com.au.