US FAST-TRACKS PHARMAXIS CYSTIC FIBROSIS DRUG.Pharmaceutical company Pharmaxis (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :PXSL), Sidney, Australia, has announced that the US Food and Drug Administration has designated Bronchitol as a fast-track product for cystic fibrosis. The FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. fast-tracks the New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) process if a therapy can potentially address an unmet medical need for a life-threatening disease. Designation as a fast-track product is designed to expedite regulatory review of the Bronchitol NDA. The FDA and European Medicines Agency The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products. Roughly parallel to the U.S. have both previously granted Bronchitol orphan drug status for treating cystic fibrosis. Pharmaxis chief executive officer Dr Alan Robertson said: "The FDA decision is encouraging news for thousands of cystic fibrosis patients. It recognises the positive clinical data for Bronchitol in treating cystic fibrosis, which is a lethal inherited condition. "This designation will speed the process of bringing this potentially life-saving drug to cystic fibrosis sufferers. "Phase II studies show Bronchitol significantly improves lung function and wellbeing in patients with cystic fibrosis. We look forward to working with the FDA on introducing Bronchitol to the U.S. market as rapidly as possible." Pharmaxis is currently conducting Phase III and II clinical trials of Bronchitol in cystic fibrosis patients at sites in Europe, Canada, Argentina and Australia. Cystic fibrosis affects approximately 75,000 people in the developed world, including 33,000 US patients and 2,500 Australians -- a fifth of whom are children under five years old. There have been no treatment advances in over a decade, and no products are approved to improve lung hydration hydration /hy·dra·tion/ (hi-dra´shun) the absorption of or combination with water. hy·dra·tion n. 1. The addition of water to a chemical molecule without hydrolysis. 2. . Designation as a fast track product enables Pharmaxis to file the new drug application on a rolling basis as data becomes available, allowing the FDA to review the application in sections ahead of receiving the complete submission. A complete submission is expected to be made in 2008. Pharmaxis is developing Bronchitol as a treatment to improve mucus clearance in the lungs of patients with cystic fibrosis, bronchiectasis bronchiectasis Abnormal expansion of bronchi in the lungs. It usually results when preexisting lung disease causes bronchial inflammation and obstruction. Bronchial wall fibres degenerate, and bronchi become dilated or paralyzed, preventing removal of secretions, which and chronic obstructive pulmonary diseases. Bronchitol is a patented, inhalable dry powder formulation of mannitol mannitol /man·ni·tol/ (man´i-tol) a sugar alcohol formed by reduction of mannose or fructose and widely distributed in plants and fungi; an osmotic diuretic used to prevent and treat acute renal failure, to promote excretion of toxic administered by a hand-held, pocket sized device. For more information, visit http://www.pharmaxis.com.au or call 212/477-9007. |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion