FDA committee votes no on Bayer's inhaled Cipro

FDA’s Antimicrobial Drugs Advisory Committee voted against approval of Cipro ciprofloxacin inhalation powder from Bayer AG (Xetra:BAYN) to reduce exacerbations in adults with non-cystic fibrosis bronchiectasis and bacterial respiratory pathogens. The committee voted 9-6 and 14-1 that Bayer did not provide substantial evidence of the safety and effectiveness of 14- and 28-day Cipro regimens, respectively, in delaying the time to first pulmonary exacerbation after starting treatment.

Bayer said it expects a decision from FDA by the end of the year...