Federal Drug Administration (FDA) Approves Drug for Complicated Urinary tract infections
The drug is administered once daily by intravenous infusion. It is indicated for patients aged 18 years or older for cUTI caused the following susceptible bacteria: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae.
The approval was supported in part by data from the phase 3 EPIC (Evaluating Plazomicin in cUTI) clinical trial, the first randomized controlled study of once-daily aminoglycoside therapy for treating cUTI, including pyelonephritis, the company said in the press release. In the trial, plazomicin demonstrated non-inferiority to meropenem for the co-primary efficacy endpoints of composite cure (clinical cure and microbiologic eradication) in the microbiological modified intent-to-treat population at day 5 and test-of-cure (TOC) visit. Composite cure rates at TOC were 81.7% for plazomicin vs 70.1% for meropenem, the company said.
In addition, composite cure at the TOC visit in patients with concomitant bacteremia at baseline was achieved in 72% of plazomicin-treated patients compared with 56.5% of meropenem recipients.
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