Breakthrough Therapy designation supports the potential of plazomicin as a substantial improvement over existing therapies
SOUTH SAN FRANCISCO, CA, USA I May 23, 2017 I Achaogen, Inc. (NASDAQ:AKAO), a late-stage biopharmaceutical company developing innovative antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for plazomicin, Achaogen’s lead product candidate being developed for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE).
The Phase 3 CARE trial data provided clinical evidence to support the 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 Company is focused on developing plazomicin as a treatment option for patients with certain severe bacterial infections, and it intends to include the CARE trial data, along with data from the EPIC trial, in an NDA submission in the second half of 2017. In 2012, the FDA granted Fast Track designation for the development and regulatory review of plazomicin to treat serious and life-threatening CRE infections. In 2014, plazomicin received Qualified Infectious Disease Product (QIDP) designation from FDA for both the cUTI and BSI indications. QIDP designation provides certain incentives for the development of new antibiotics, including automatic priority review and an additional five years of market exclusivity.
About Breakthrough Therapy Designation
Breakthrough Therapy designation was created by the FDA to expedite the development and review of drugs that target serious or life-threatening conditions. A Breakthrough Therapy drug must show preliminary clinical evidence of a substantial improvement on a clinically significant endpoint over available therapies. The designation includes all of the Fast Track program features, as well as more intensive FDA guidance and discussion, including interactions with FDA across review divisions.
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, Achaogen’s lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. FDA has granted plazomicin Breakthrough Therapy designation for the treatment of bloodstream infections (BSI) caused by certain Enterobacteriaceae in patients who have limited or no alternative treatment options. Achaogen’s plazomicin program is funded in part with Federal funds from the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201000046C. Plazomicin is the first clinical candidate from Achaogen’s gram-negative antibiotic discovery engine, and Achaogen has other programs in early and late preclinical stages focused on other MDR gram-negative infections. All product candidates are investigational only and have not been approved for commercialization. For more information, please visit www.achaogen.com.
SOURCE: Achaogen
Post Views: 36
Breakthrough Therapy designation supports the potential of plazomicin as a substantial improvement over existing therapies
SOUTH SAN FRANCISCO, CA, USA I May 23, 2017 I Achaogen, Inc. (NASDAQ:AKAO), a late-stage biopharmaceutical company developing innovative antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for plazomicin, Achaogen’s lead product candidate being developed for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE).
The Phase 3 CARE trial data provided clinical evidence to support the 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 Company is focused on developing plazomicin as a treatment option for patients with certain severe bacterial infections, and it intends to include the CARE trial data, along with data from the EPIC trial, in an NDA submission in the second half of 2017. In 2012, the FDA granted Fast Track designation for the development and regulatory review of plazomicin to treat serious and life-threatening CRE infections. In 2014, plazomicin received Qualified Infectious Disease Product (QIDP) designation from FDA for both the cUTI and BSI indications. QIDP designation provides certain incentives for the development of new antibiotics, including automatic priority review and an additional five years of market exclusivity.
About Breakthrough Therapy Designation
Breakthrough Therapy designation was created by the FDA to expedite the development and review of drugs that target serious or life-threatening conditions. A Breakthrough Therapy drug must show preliminary clinical evidence of a substantial improvement on a clinically significant endpoint over available therapies. The designation includes all of the Fast Track program features, as well as more intensive FDA guidance and discussion, including interactions with FDA across review divisions.
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, Achaogen’s lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. FDA has granted plazomicin Breakthrough Therapy designation for the treatment of bloodstream infections (BSI) caused by certain Enterobacteriaceae in patients who have limited or no alternative treatment options. Achaogen’s plazomicin program is funded in part with Federal funds from the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201000046C. Plazomicin is the first clinical candidate from Achaogen’s gram-negative antibiotic discovery engine, and Achaogen has other programs in early and late preclinical stages focused on other MDR gram-negative infections. All product candidates are investigational only and have not been approved for commercialization. For more information, please visit www.achaogen.com.
SOURCE: Achaogen
Post Views: 36
