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Achaogen antibacterial gets FDA breakthrough status

May 23, 2017

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.


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