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Panel rebuffs Pharmaxis' Bronchitol for CF

January 31, 2013 2:08 AM UTC

FDA's Pulmonary-Allergy Drugs Advisory Committee voted 14-0 against approval of an NDA for Bronchitol mannitol from Pharmaxis Ltd. (ASX:PXS; Pink:PXSLY) to improve pulmonary function in cystic fibrosis (CF) patients six years of age and older. The committee also voted 11-3 in two separate votes that Pharmaxis had not provided sufficient evidence of Bronchitol's efficacy and safety. Echoing concerns raised by FDA reviewers in briefing documents released on Monday, the panel noted that Bronchitol had only met the primary endpoint in one of two Phase III trials. The formulation of mannitol in a dry powder inhaler system has a March 18 PDUFA date (see BioCentury Extra, Jan. 28). ...