Treatment for Urinary Tract Infection
Achaogen Submits Plazomicin New Drug Application (NDA) to the U.S. FDA for Treatment of Complicated Urinary Tract Infections and Bloodstream Infections
SOUTH SAN FRANCISCO, Calif., Oct. 26, 2017 (GLOBE NEWSWIRE) — Achaogen, Inc. (NASDAQ:AKAO), a late-stage biopharmaceutical company developing innovative antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for plazomicin, seeking approval to treat 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. The company also intends to submit an application for registration in the European Union (EU) in 2018.
“The submission of the plazomicin NDA is a major step towards the potential commercialization of an important antibacterial to address multi-drug resistant gram-negative infections. I am especially proud of the Achaogen team who has worked tirelessly to prepare the submission, and of our hospital medical teams who conducted our clinical trials,” said Kenneth Hillan, M.B. Ch.B., Achaogen’s Chief Executive Officer. “Based on our clinical trial results, we believe that plazomicin, if approved, would be a valuable new option for the infectious disease community to treat patients with serious bacterial infections, including infections due to CRE.”
The NDA includes 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 carbapenem-resistant Enterobacteriaceae (CRE). The FDA has 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. The FDA has also granted fast track designation for the development and regulatory review of plazomicin to treat serious and life-threatening CRE infections. Plazomicin has received Qualified Infectious Disease Product (QIDP) designation from the FDA with the objective of providing certain incentives for the development of new antibiotics, including priority review and an additional five years of market exclusivity.
Plazomicin was developed to treat serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE), and has been evaluated in two Phase 3 clinical trials, EPIC and CARE.
About Multi-Drug Resistant (MDR) Gram-Negative Infections
Multidrug resistant gram-negative bacteria, including carbapenem-resistant Enterobacteriaceae (CRE), are a type of gram-negative bacteria with resistance to multiple antibiotics. They can cause bacterial infections that 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”. 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. The Food and Drug Administration has granted plazomicin Breakthrough Therapy designation for the treatment of bloodstream infections caused by certain Enterobacteriaceae in patients who have limited or no alternative treatment options. 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, please visit www.achaogen.com.
This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Achaogen’s expectations regarding potential regulatory approval of plazomicin, Achaogen’s commercial objectives and Achaogen’s pipeline of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Achaogen’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; the uncertainties of having an NDA accepted by the FDA, the risks and uncertainties of the regulatory approval process; the risks and uncertainties of commercialization and gaining market acceptance; the risk when bacteria will evolve resistance to plazomicin; Achaogen’s reliance on third-party contract manufacturing organizations to manufacture and supply its product candidates and certain raw materials used in the production thereof; risk of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate Achaogen’s patents or proprietary rights; and the risk that Achaogen’s proprietary rights may be insufficient to protect its technologies and product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Achaogen’s business in general, see Achaogen’s current and future reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K filed on March 14, 2017 and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2017. Achaogen does not plan to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise.
Source: Achaogen, Inc.
Posted: October 2017
plazomicin FDA Approval History