ARTICLE | Clinical News

Achaogen antibiotic gets FDA panel date

March 23, 2018 5:59 PM UTC

Achaogen Inc. (NASDAQ:AKAO) said FDA's Antimicrobial Drugs Advisory Committee will meet on May 2 to discuss the company's NDA for plazomicin (formerly ACHN-490) to treat complicated urinary tract infections (cUTIs), including pyelonephritis, and bloodstream infections due to Enterobacteriaceae in patients with limited or no alternative treatment options.

Plazomicin, a next-generation aminoglycoside antibiotic, is under Priority Review. Its PDUFA date is June 25. Achaogen had expected FDA to convene an advisory committee meeting (see BioCentury, Jan. 3)...