Achaogen:FDA Declines To Approve Treatment For Bloodstream Infection; Stock Down

(RTTNews) - Achaogen Inc. (AKAO) said that, regarding the potential indication for plazomicin for the treatment of bloodstream infection, the U.S. Food and Drug Administration issued a Complete Response Letter or CRL stating that the CARE study does not provide substantial evidence of effectiveness of plazomicin for the treatment of bloodstream infection or BSI. The company plans to meet with the FDA to determine whether there is a feasible resolution to address the CRL.

In the Tuesday's pre-market trade, AKAO is trading at $10.60, down $1.42 or 11.81%.

The company also announced that the U.S. Food and Drug Administration has approved ZEMDRI (plazomicin) for adults with complicated urinary tract infections or cUTI, including pyelonephritis, caused by certain Enterobacteriaceae in patients who have limited or no alternative treatment options. ZEMDRI is an intravenous infusion, administered once daily.

The approval of ZEMDRI is supported in part by data from the EPIC (Evaluating Plazomicin In cUTI) clinical trial, which was the first randomized controlled study of once-daily aminoglycoside therapy for the treatment of cUTI, including pyelonephritis.