FDA approves plazomicin for cUTI, but not blood infections

Achaogen Inc. (NASDAQ:AKAO) said FDA approved Zemdri plazomicin to treat complicated urinary tract infections (cUTIs), but issued a complete response letter for the same candidate to treat bloodstream infections. The mixed decision is in line with the outcome of a May FDA advisory committee meeting.

Zemdri is indicated to treat cUTI, including pyelonephritis, caused by certain Enterobacteriaceae in adults with limited or no alternative treatment options. The U.S. label includes a black box warning for risks of nephrotoxicity, ototoxicity, neuromuscular blockade and fetal harm...