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Pharmaxis’ Bronchitol Will Face Efficacy Questions At FDA Panel Review

 
• By Sue Sutter

Several statistical issues, including differential rates of missing data between treatment arms in the pivotal studies, make it difficult to assess mannitol’s benefit in cystic fibrosis patients, FDA says in briefing documents for the Pulmonary-Allergy Drugs Advisory Committee’s Jan. 30 meeting.

Pharmaxis Ltd. will need to overcome a host of statistical challenges to the efficacy of its cystic fibrosis drug Bronchitol (mannitol inhalation powder) to gain an FDA advisory committee’s endorsement Jan. 30.

In briefing documents released ahead of the Pulmonary-Allergy Drugs Advisory Committee’s meeting, FDA reviewers said their determination of mannitol’s efficacy...

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