Achaogen Announces FDA Acceptance of New Drug Application With Priority Review

Achaogen, Inc. recently announced the US FDA has accepted for review the company’s 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. FDA has granted the NDA Priority Review and set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 25, 2018. Achaogen also intends to submit an application for marketing authorization in the European Union (EU) in 2018.

“The number of confirmed cases of CRE annually in the US is at least 70,000, and is projected to double by 2022,” said Blake Wise, Achaogen’s Chief Executive Officer. “We are excited about plazomicin’s potential to address certain multi-drug resistant gram-negative infections and feel that plazomicin would be a valuable new treatment option for patients with serious bacterial infections, including those due to CRE and ESBL-producing Enterobacteriaceae.”

In its acceptance letter, the FDA has stated that it is currently planning to hold an advisory committee meeting to discuss this application. The NDA is supported by data from both the EPIC and CARE clinical trials which evaluated the safety and efficacy of plazomicin in patients with serious infections caused by gram-negative pathogens, including extended-spectrum beta-lactamase (ESBL) producing and carbapenem-resistant Enterobacteriaceae (CRE). The FDA granted Breakthrough Therapy designation for plazomicin for the treatment of bloodstream infections (BSI) caused by certain Enterobacteriaceae in patients who have limited or no alternative treatment options. Breakthrough Therapy designation was created by the FDA to expedite the development and review of drugs that target serious or life-threatening conditions. Plazomicin has also received Qualified Infectious Disease Product (QIDP) designation from the FDA which provides incentives for the development of new antibiotics, including priority review and an additional five years of market exclusivity.

A Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. The FDA goal for reviewing a drug with Priority Review status is 6 months from the time the application is filed by the FDA.

Plazomicin was developed to treat serious bacterial infections due to MDR Enterobacteriaceae, including extended-spectrum beta-lactamase (ESBL) producing and carbapenem-resistant Enterobacteriaceae (CRE), and has been evaluated in two Phase 3 clinical trials, EPIC and CARE.

Multidrug resistant gram-negative bacteria, including carbapenem-resistant Enterobacteriaceae (CRE), are gram-negative bacteria that are resistant to multiple antibiotics and pose a serious threat for hospitalized patients. The problem is extensive and growing; the Centers for Disease Control and Prevention (CDC) characterized CRE as “nightmare bacteria” and an immediate public health threat that requires “urgent and aggressive action”. The CDC characterized ESBL-producing bacteria as a serious threat to public health. Patients with MDR infections often have limited or inadequate therapeutic options leading to high rates of mortality.

Achaogen is a late-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of innovative antibacterial treatments for MDR gram-negative infections. Achaogen is developing plazomicin, its lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. Achaogen’s plazomicin program has been funded in part with Federal funds from the Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201000046C. The company’s second product candidate is C-Scape, an orally-administered beta-lactam/beta-lactamase inhibitor combination. Achaogen has other programs in early and late preclinical stages focused on other MDR gram-negative infections and additional disease areas. All product candidates, including plazomicin, are investigational only and have not been approved for commercialization. For more information, visit www.achaogen.com.