Bayer's Inhaled Cipro Cannot Surmount Inconsistent Efficacy Data At US FDA Panel

17 Nov 2017

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.

Inconsistent Phase III efficacy results for Bayer HealthCare Pharmaceuticals AG's inhalable ciprofloxacin in treating bronchiectasis, coupled with uncertainties about long-term benefit and antimicrobial resistance, proved too troubling for the majority of US FDA advisory committee members Nov. 16.

The Antimicrobial Drugs Advisory Committee narrowly voted that Bayer had not demonstrated substantial evidence of efficacy and safety for a...