— Investigational drug has potential to treat certain MDR gram-negative pathogens, including carbapenem-resistant Enterobacteriaceae (CRE) —
SOUTH SAN FRANCISCO, CA, USA I October 26, 2017 I 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.
About Plazomicin
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.
About Achaogen
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.
SOURCE: Achaogen
Post Views: 21
— Investigational drug has potential to treat certain MDR gram-negative pathogens, including carbapenem-resistant Enterobacteriaceae (CRE) —
SOUTH SAN FRANCISCO, CA, USA I October 26, 2017 I 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.
About Plazomicin
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.
About Achaogen
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.
SOURCE: Achaogen
Post Views: 21
