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Chiesi Takes CF Product To Advisory Cmte. With Modest Efficacy, Many Questions

 
• By Michael Cipriano

Bronchitol is set to make its second appearance before a US FDA advisory committee, and Chiesi hopes to rely on the drug’s novel mechanism of action and the unmet need in cystic fibrosis to overcome the agency’s concerns about the underlying clinical data.

Cystic fibrosis word cloud

The US Food and Drug Administration appears to be somewhat sour on the modest efficacy of Pharmaxis Ltd.'s cystic fibrosis treatment Bronchitol (mannitol inhalation powder), and the sponsor may need the Pulmonary-Allergy Drugs Advisory Committee to be sympathetic to the drug's unique mechanism and the disease's unmet need for additional treatments to have a shot at approval.

The committee will convene 8 May to assess the risk/benefit profile of Bronchitol, as Chiesi USA Inc

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