Bayer's Inhaled Cipro Cannot Surmount Inconsistent Efficacy Data At US FDA Panel
Advisory committee recommends against approval of dry powder formulation for treating non-cystic fibrosis bronchiectasis due to inconsistent results in Phase III RESPIRE trials and concerns about long-term benefit and antibiotic resistance.
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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.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
Advisory committee asked to opine on whether there is substantial evidence of efficacy even though Phase III studies missed on three of four primary efficacy measures; Bayer argues that totality of the evidence demonstrates a meaningful benefit in reducing exacerbations in a heterogeneous patient population with the rare disease.