FDA Approves Plazomicin for Treatment of Complicated Urinary Tract Infection

Officials with the FDA have approved plazomicin (Zemdri, Achaogen) for the treatment of adults with complicated urinary tract infections (cUTIs), caused by certain Enterobacteriaceae, in patients with limited or no alternative treatment. 

According to Achaogen, plazomicin has microbiological activity against pathogens including carbapenem-resistant (CRE) and extended-spectrum beta-lactamase (ESBL) producing Enterobacteriaceae.


Plazomicin is the only once-daily aminoglycoside therapy approved for use in cUTI and is an intravenous infusion, administered once per day.

“Among the multidrug-resistant bacteria, gram-negatives are a most pressing concern. And, of that, there are different issues with the different species that we see causing antibiotic resistance,” stressed Jason Gallagher, PharmD, clinical professor, Temple University School of Pharmacy, who serves as editor-in-chief of Contagion®, Specialty Pharmacy Times' sister website.

In phase 3 clinical trial, Evaluating Plazomicin in cUti (EPIC), plazomicin demonstrated non-inferiority to meropenem for the co-primary efficacy endpoints of composite cure in the microbiological modified intent to treat population in the treatment of adult patients with cUTI.

Click to continue reading on Contagion. 


Stay up to date on the latest news in specialty pharmacy by getting Specialty Pharmacy Times in your mailbox or inbox for free!

Click here to sign up for free for the bi-monthly Specialty Pharmacy Times print journal delivered to your address.

Click here to sign up for our email newsletters delivered every Monday, Wednesday, and Friday, in addition to breaking news alerts.

Click here to follow us on Facebook. 

Click here to follow us on Twitter. 

Click here to join our LinkedIn group. 


Related Articles

In 2016, an estimated 93% incident HIV infections among black women would not have occurred if the incidence for black women were the same as that for white women, according a CDC report.
Antibiotic-resistant Acinetobacter baumannii infections put children with compromised immune systems in health care settings at greater risk of infections of the lung, urinary tract, and other sites.
Women with a prior chlamydia infection could have twice the risk of ovarian cancer.
Company Profile >
Industry Guide >
Market News >
Peer Exchange >
Conferences >
Subscribe >
Specialty Times Resources
About Us
Advertise
Careers
Contact Us
Terms & Conditions
Privacy
MJH Associates >
Pharmacy Times
OTCGuide
American Journal of Managed Care
Cure
MD Magazine
ONCLive
Targeted Oncology
Physicians' Education Resource
Pharmacy & Healthcare Communications, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-716-4747

Copyright Specialty Pharmacy Times 2006-2018
Pharmacy & Healthcare Communications, LLC. All Rights Reserved.
 

$vacMongoViewPlus$