FDA drug committee denies Achaogen's plazomicin for use in blood stream infections; shares fall

The FDA’s Antimicrobial Drugs Advisory committee has voted overwhelmingly in favor that biopharma Achaogen Inc’s (NASDAQ:AKAO) data supports the safety and effectiveness of plazomicin, its treatment for complicated urinary tract infections.

Investors did not cheer the news, however, as the same FDA committee voted in an 11 to 4 tally that the data failed to provide substantial evidence of the safety and efficacy of plazomicin when used in bloodstream infections endured by patients with limited or no treatment options.

In morning trade, Achaogen shares fell sharply by 28% to US$10.52.

Achaogen is developing its lead drug plazomicin for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae.

The FDA is not bound by the committee’s vote, but takes its input into consideration when reviewing drug marketing applications.

Story by ProactiveInvestors