— ZEMDRI is the alone once-daily aminoglycoside analysis FDA-approved for use in complicated urinary amplitude infections (cUTI) —
— Analysis with ZEMDRI resulted in a greater than four-fold abridgement in backsliding of cUTI analytic affection compared to meropenem at Day 28 —
SOUTH SAN FRANCISCO, Calif., Feb. 21, 2019 (GLOBE NEWSWIRE) — Achaogen, Inc. (AKAO), a biopharmaceutical aggregation discovering, developing and commercializing avant-garde antibacterial agents to abode multi-drug advancing (MDR) gram-negative infections, today announced that the New England Journal of Medicine has appear the after-effects from the Phase 3 EPIC (Evaluating Plazomicin In cUTI) abstraction of ZEMDRI. The advertisement describes the ability and assurance of ZEMDRI in developed patients with complicated urinary amplitude infections (cUTI), including astute pyelonephritis. The commodity appears in the February 21, 2019 affair of the Journal.
“The able analysis of complicated urinary amplitude infections is added acceptable added arduous because of the growing botheration of antimicrobial resistance,” said Florian M.E. Wagenlehner, M.D., Director, Clinic for Urology, Pediatric Urology and Andrology, Justus Liebig University Giessen, Germany. “The randomized analytic balloon EPIC auspiciously evaluated plazomicin, which is a once-daily aminoglycoside for cUTI with biological activity adjoin multi-drug advancing bacteria. The abeyant for ZEMDRI to abode difficult-to-treat infections and my abundance with its assurance contour are important attributes back because a patient’s analysis options.”
The Phase 3 EPIC analytic balloon was the aboriginal multicenter, multinational, randomized, double-blind and controlled abstraction of once-daily aminoglycoside analysis for the analysis of cUTI, including astute pyelonephritis. The article, advantaged Once-Daily Plazomicin for Complicated Urinary Amplitude Infections is abbreviated as follows:
About cUTIcUTI is authentic as a UTI occurring in a accommodating with an basal complicating agency of the genitourinary tract, such as a structural or anatomic abnormality.2 Patients with pyelonephritis, behindhand of basal abnormalities of the urinary tract, are advised a subset of patients with cUTI.3 An estimated 3 actor cases of cUTI are advised in the hospital ambience in the U.S. anniversary year.4 Enterobacteriaceae are the best accepted bacilli causing cUTIs5, and attrition aural this ancestors is a all-around concern. High ante of attrition to antecedent mainstays of analysis necessitate another analysis options. Ineffectively managed cUTI can advance to added analysis abortion rates, ceremony of infection, added re-hospitalization, and added anguish and mortality. cUTI infections abode an bread-and-butter accountability on hospitals and payers.5,6
About ZEMDRIZEMDRI is an aminoglycoside with once-daily dosing that has activity adjoin assertive Enterobacteriaceae. Achaogen’s EPIC analytic balloon auspiciously evaluated the assurance and ability of ZEMDRI in developed patients with cUTI, including pyelonephritis. ZEMDRI was engineered to affected aminoglycoside-modifying enzymes, the best accepted aminoglycoside-resistance apparatus in Enterobacteriaceae, and has in vitro activity adjoin ESBL- producing, aminoglycoside- resistant, and carbapenem- advancing isolates. The Centers for Disease Control and Prevention has characterized ESBL- bearing Enterobacteriaceae as a “serious threat” and carbapenem-resistant Enterobacteriaceae (CRE) as “nightmare bacteria,” which is an absolute accessible bloom blackmail that requires burning and advancing action.
Indications & UsageZEMDRI is adumbrated in patients 18 years of age or earlier for the analysis of complicated urinary amplitude infections (cUTI), including pyelonephritis acquired by the afterward affected microorganism(s): Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and Enterobacter cloacae.
As alone bound analytic assurance and ability abstracts for ZEMDRI are currently available, assets ZEMDRI for use in cUTI patients who accept bound or no another analysis options.
To abate the development of drug-resistant bacilli and advance capability of ZEMDRI and added antibacterial drugs, ZEMDRI should be acclimated alone to amusement or anticipate infections that are accurate or acerb doubtable to be acquired by affected microorganisms.
Important Assurance Information
BOXED WARNINGS: NEPHROTOXICITY, OTOTOXICITY, NEUROMUSCULAR BLOCKADE AND FETAL HARM
Contraindications: ZEMDRI is contraindicated in patients with accepted hypersensitivity to any aminoglycoside.
Additional Warnings and Precautions
Please bang actuality to see the abounding Prescribing Information, including BOXED WARNINGS, for added Important Assurance Information.
You may address ancillary furnishings to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may additionally address ancillary furnishings to Achaogen at (833) AKAO-402.
About AchaogenAchaogen is a biopharmaceutical aggregation foolishly committed to the discovery, development, and commercialization of avant-garde antibacterial treatments for MDR gram-negative infections. Achaogen’s aboriginal bartering artefact is ZEMDRI, for the analysis of adults with complicated urinary amplitude infections (cUTI), including pyelonephritis. The Achaogen ZEMDRI affairs was adjourned in allotment with federal funds from the Biomedical Advanced Research and Development Authority (BARDA). The Aggregation is currently developing C-Scape, an orally-administered beta-lactam/beta-lactamase inhibitor combination, which is additionally accurate by BARDA. C-Scape is investigational, has not been bent to be safe or efficacious, and has not been accustomed for commercialization. For added information, appointment the Achaogen website at www.achaogen.com.
Forward-Looking StatementsThis columnist absolution contains advanced statements. All statements added than statements of absolute facts independent herein are advanced statements absorption the accepted behavior and expectations of administration fabricated pursuant to the safe anchorage accoutrement of the Private Securities Litigation Reform Act of 1995, including, but not bound to, the abeyant uses and advantages of ZEMDRI, Achaogen’s bartering objectives and the Achaogen activity of artefact candidates. Such advanced statements absorb accepted and alien risks, uncertainties, and added important factors that may account Achaogen’s absolute results, performance, or achievements to be materially altered from any approaching results, performance, or achievements bidding or adumbrated by the advanced statements. Such risks and uncertainties include, amid others, the risks and uncertainties of the authoritative approval process; bazaar admeasurement and growth; timing of activities, including barrage dates of products; statements about the efficacy, assurance and tolerability of ZEMDRI and artefact candidates; the risks and uncertainties of artefact sales; the accident of back bacilli will advance attrition to ZEMDRI and artefact candidates; Achaogen’s assurance on third-party arrangement accomplishment organizations for accomplish and supply, including sources of assertive raw materials; accident of third-party claims alleging contravention of patents and proprietary rights or gluttonous to invalidate Achaogen’s patents or proprietary rights; and the accident that Achaogen’s proprietary rights may be bereft to assure its technologies and artefact candidates. For a added description of the risks and uncertainties that could account absolute after-effects to alter from those bidding in these advanced statements, as able-bodied as risks apropos to the Achaogen business in general, see Achaogen accepted and approaching letters filed with the Securities and Exchange Commission, including its Annual Address on Form 10-K filed on February 27, 2018, and its Quarterly Address on Form 10-Q filed on November 8, 2018. Achaogen does not plan to about amend or alter any advanced statements independent in this columnist release, whether as a aftereffect of any new information, approaching events, afflicted circumstances, or otherwise.
1 Wagenlehner FME, Cloutier DJ, Komirenko AS, et al. Once-Daily Plazomicin for Complicated Urinary Amplitude Infections. N Engl J Med 2019;380:729-40.
2 Nicolle LE. J Infect Dis. 2001;183(Suppl 1):S5-8.
3 U.S. Food & Drug. Complicated Urinary Amplitude Infections: Developing Drugs for Analysis Guidance for Industry. https://www.fda.gov/downloads/Drugs/Guidances/ucm070981.pdf. Accessed June 25, 2018.
4 Decision Resources Disease Landscape & Forecast, Hospital-Treated Gram-Negative Infections, September 2017; abstracts on file.
5 Bader MS et al. Postgrad Med. 2010;122(6):7-15.
6 Turner RM et al. Clin Ther. 2015;37(9):2037-2047.
Source: Achaogen, Inc.
Investor and Media Contact:Denise [email protected]
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