Pharmaxis Meeting FDA to Discuss Bronchitol for Cystic Fibrosis; Business Review Announcement End of May
Release Date: 14/05/2013 12:00am
Pharmaceutical company Pharmaxis (ASX: PXS) announced it will meet this week with representatives of the Food and Drug Administration (FDA) to discuss the key parameters of the clinical trial necessary to secure approval for Bronchitol® (mannitol) for the treatment of cystic fibrosis in the USA.
The Type A meeting with the Division of Pulmonary, Allergy and Rheumatology Products (DPARP) will be attended by members of Pharmaxis’ medical and regulatory teams and will take place in Maryland, USA.
Pharmaxis CEO Mr Gary Phillips said, “This meeting is an opportunity for a structured discussion with the FDA on key points of its evaluation of the Company’s New Drug Application and the pathway for approval of Bronchitol. Pharmaxis is seeking guidance so it can design a clinical trial to meet the FDA’s requirements for substantial evidence of the efficacy of Bronchitol in patients with cystic fibrosis.
“The outcome of the FDA meeting will allow Pharmaxis to finalise a business review and implement a phased restructuring based around the expected delay to US revenue and the approval paths for Bronchitol in cystic fibrosis and bronchiectasis. The results of this review will be announced by the end of May 2013.”
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