FDA Approves New Antibiotics to Treat Kidney Infections by “Superbugs”

August 31, 2017  Source: medgenera 281

Adult peoples with complicated urinary tract infections (cUTI) like pyelonephritis–  a type of kidney infection caused by specific bacteria- suffer from many inconvenient problems like painful urination. It may lead to serious life threatening conditions including permanent kidney damage.

The Medicines Company’s Vabomere received US FDA approval to treat adult patients having cUTI. Vabomere is a fixed-dose combination of the antibiotics- carbapenem, meropenem, and the novel beta-lactamase inhibitor, vaborbactam.

Various gram-negative bacteria like Klebsiella sp., E. coli, Enterobacter sp. and others produce new beta-lactamase enzymes that are prevalent in many places in the US and Europe, particularly the Klebsiella pneumoniae carbapenemase (KPC) enzyme.

The enzyme degrades antibiotics and causes severe gram-negative infections like cUTI. Hence, the bacteria causing the infections become resistant to the currently available antibiotics-  carbapenems.

Vabomere includes a new beta-lactamase inhibitor, vaborbactam which is capable of addressing these severe forms of resistant bacteria.

During the clinical development of Vabomere, it improved the rate of cure in patients having different forms of infections and reduced the rate of adverse effects in the kidney.

545 patients with cUTI were evaluated during the clinical study of Vabomere. About 98 percent patients treated with Vabomere showed improvements in their disease symptoms compared to 94 percent of the patients who were treated with another antibacterial drug, piperacillin/tazobactam.

Seven days after the completion of the treatment 77 percent of Vabomere-treated patients got completely relieved from the disease symptoms compared to 73 percent of patients treated with piperacillin/tazobactam.

Serious drug-resistant infections in patients increase the cost of care for hospitals and increase the mortality rate in patients. When the existing line of antibiotics fails to treat patients, doctors give a combination of several older antibiotics, many of which may cause severe toxicities and adverse events.

In order to avoid the development of resistance against the newly-approved antibiotic, Vabomere, it should be only used to treat or prevent infections only in those patients who have confirmed or strongly suspected cases of susceptible bacteria infections.

 

By Ddu
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