Bronchitol mannitol regulatory update

FDA's Pulmonary-Allergy Drugs Advisory Committee voted 14-0 against approval of an NDA for Bronchitol mannitol from Pharmaxis to improve pulmonary function in cystic fibrosis patients >=6 years of age. The committee also voted 11-3 in 2 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 last week, the panel noted that Bronchitol had only met the primary endpoint in 1 of 2 Phase III trials. The formulation of mannitol in a dry powder inhaler system has a March 18 PDUFA date. ...