FDA Accepts Plazomicin’s NDA with Priority Review for the Treatment of Complicated Urinary Tract Infections and Bloodstream Infections

PDUFA date of June 25, 2018

Achaogen, Inc. recently announced the U.S. Food and Drug Administration’s (FDA) acceptance of the New Drug Application (NDA) for plazomicin for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, and bloodstream infections (BSI) due to certain Enterobacteriaceae in patients who have limited or no alternative treatment options. In 2006, Ionis licensed a proprietary aminoglycoside program to Achaogen from which plazomicin was discovered. Ionis is eligible to receive a low, single-digit royalty on sales of plazomicin, if it is granted marketing approval.

The NDA includes data from EPIC and CARE – two positive, Phase 3 studies evaluating the safety and efficacy of plazomicin in patients with serious infections that are resistant to multiple antibiotics. The application was given Priority Review with a target action date of June 25, 2018. The FDA grants Priority Review to drugs that have the potential for major advances in the treatment of a disease or in cases where no adequate therapy currently exists. Once the application is filed and accepted, the FDA has six months to review a drug that has been awarded Priority Review. During development, plazomicin received Breakthrough Therapy designation to expedite both the development and review. Prior to submission, plazomicin also received Qualified Infectious Disease (QIDP) designation, allowing an additional five years of market exclusivity in addition to Priority Review. With a rapidly growing number of patients in the U.S. infected annually with antibiotic resistant infections, we believe there is significant commercial opportunity for plazomicin, if approved.1

Achaogen also announced plans to submit a marketing authorization application (MAA) to the European medicines agency (EMA) in 2018.

For more information please visit the Achaogen, Inc. website at www.achaogen.com.

Reference

  1. Logan LK, Weinstein RA. J Infect Dis. 2017; 215 (suppl 1): S28-S36.