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Ciprofloxacin For Bronchiectasis: Can Aradigm Avoid Bayer's Fate At US FDA Panel?

Executive Summary

Linhaliq, an inhaled form of ciprofloxacin, appears to raise same efficacy, study design, and resistance concerns as those that resulted in a negative advisory committee review and FDA complete response for Bayer's formulation of the fluoroquinolone.

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Aradigm's Linhaliq Suffers 'No' For Reducing Time To Exacerbations At US FDA Panel

Discordant results on Phase III primary endpoint in non-cystic fibrosis bronchiectasis patients troubled advisory committee members, although some suggested they would be more open to approval based upon secondary endpoint data on reduction in exacerbation frequency.

Bronchiectasis Trials Should Be Longer, Focus On Exacerbation Frequency

Bayer's endpoint for Phase III trials of ciprofloxacin inhaler should have focused on frequency of, rather than delay in, exacerbations, US FDA advisory committee members say; Aradigm's pending NDA in non-cystic fibrosis bronchiectasis could be impacted recommendations on endpoints, trial duration and concerns about long-term development of antibiotic resistance.

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