FDA accepts Pharmaxis’ Aridol NDA for review

May 13 2009

Pharmaxis has announced it had received notification from the United States Food and Drug Administration (FDA) that the New Drug Application (NDA) for its mannitol bronchial challenge test Aridol has been accepted for standard review. The FDA will advise the result of the review on 27 December 2009.

Pharmaxis is seeking approval for Aridol for "the assessment of bronchial hyperresponsiveness to aid in the diagnosis of patients with symptoms of or suggestive of asthma." Asthma affects more than 34 million people in the U.S. with an annual economic cost of $19.7 billion. When approved, Aridol will be the first dry powder bronchial challenge test available in the U.S.

Alan Robertson, Pharmaxis Chief Executive Officer said: "We have been greatly encouraged by the interest respiratory physicians have shown in Aridol at recent U.S. scientific conferences. We estimate that 200,000 bronchial hyper-responsiveness tests are performed in the US each year and hope that the introduction of a dry powder test kit will encourage more physicians to utilize this test when diagnosing asthma. We look forward to working with the FDA to complete the review."

Aridol is approved for sale in most major European countries, Australia and Korea. Aridol has been included in the Global Initiative for Asthma guidelines, and in the U.S. Asthma Management Guidelines. It is one of the tests recommended by the World Anti-Doping Agency, and other sports governing bodies to ensure elite athletes who are asthmatic are properly diagnosed and treated.