Achaogen, Inc. announced that ZEMDRI is now available for ordering. ZEMDRI is approved in the United States for the treatment of adults with cUTI, including pyelonephritis, due to certain Enterobacteriaceae. ZEMDRI was approved by the U.S. Food and Drug Administration on June 25, 2018. ZEMDRI for injection 500 mg/10 mL (50mg/mL) is supplied in single-use, clear glass vials (ten vials per carton). ZEMDRI dosing is based on patient weight and renal function; Achaogen expects that most patients receiving the standard dose will receive three vials per daily dose. ZEMDRI is available for purchase through specialty distributors such as ASD Healthcare, a company of AmerisourceBergen, Cardinal Health Specialty Distribution, FFF Enterprises and McKesson Plasma and Biologics. The approval of ZEMDRI was supported in part by data from the EPIC (Evaluating Plazomicin In cUTI) clinical trial, which was the first randomized controlled study of once-daily aminoglycoside therapy for the treatment of cUTI, including pyelonephritis. In the Phase 3 EPIC cUTI clinical trial, ZEMDRI demonstrated non-inferiority to meropenem for the co-primary efficacy endpoints of composite cure (clinical cure and microbiological eradication) in the microbiological modified intent-to-treat (mMITT; N=388) population at Day 5 and test-of-cure (TOC) visit (Day 17 + 2). Composite cure rates at Day 5 were 88.0% (168/191) for ZEMDRI vs. 91.4% (180/197) for meropenem (difference -3.4%, 95% CI, -10.0 to 3.1). Composite cure rates at TOC were 81.7% (156/191) for ZEMDRI vs. 70.1% (138/197) for meropenem (difference 11.6%, 95% CI, 2.7 to 20.3). Composite cure at the TOC visit in patients with concomitant bacteremia at baseline was achieved in 72.0% (18/25) of patients in the ZEMDRI group vs. 56.5% (13/23) in the meropenem group.1 Relapse of clinical cUTI symptoms at late follow up (LFU, day 28 +/- 4) occurred in 1.6% (3/191) of ZEMDRI-treated patients compared with 7.1% (14/197) of meropenem-treated patients, and microbiological recurrence of the baseline uropathogens at LFU occurred in 3.7% (7/191) of ZEMDRI-treated patients compared with 8.1% (16/197) of meropenem-treated patients.2 The most common side effects (=1% of patients treated with ZEMDRI) are decreased renal function, diarrhea, hypertension, headache, nausea, vomiting, and hypotension.
Achaogen, Inc. is a late-stage biopharmaceutical company. The Company is engaged in the discovery, development and commercialization of antibacterial treatments against multi-drug resistant (MDR) gram-negative infections. The Company is involved in researching and developing plazomicin, its lead product candidate, for the treatment of serious bacterial infections, including complicated urinary tract infection (cUTI), blood stream infections and other infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE). Plazomicin is an intravenous aminoglycoside antibiotic. The Company has developed plazomicin by chemically modifying sisomicin, a naturally occurring aminoglycoside, in order to overcome common aminoglycoside resistance mechanisms. The Company has a portfolio of small molecule and antibody programs. The Company's Early Development programs include C-Scape and LpxC.
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