EU Regulators OK Antibiotic Zavicefta for Resistant Bugs

Disclosures

April 29, 2016

The European Medicines Agency (EMA) has recommended approval of the antibiotic ceftazidime/avibactam (Zavicefta, AstraZeneca) as a new option against multidrug-resistant bacteria, the European Union (EU) agency announced today.

The EMA's Committee for Medicinal Products for Human Use also voted in favor of an antiseptic gel consisting of chlorhexidine digluconate (Umbipro, GlaxoSmithKline) to prevent umbilical cord infections in developing countries outside the EU.

The new weapon against antibiotic resistance combines an established drug and a newcomer. Ceftazidime is a third-generation cephalosporin already approved in the EU. Avibactam is a new beta-lactamase inhibitor. The beta-lactamase enzyme deactivates ceftazidime, so the inhibitor restores the antibiotic's power. Avibactam also counters enzymes produced by bacteria to deactivate the class of antibiotics called carbapenems.

The EMA notes rising resistance to ceftazidime as well as carbapenems, particularly among Gram-negative bacteria such as those in the Enterobacteriaceae family.

The combination drug is indicated for adults with intra-abdominal and urinary tract infections and pneumonia acquired in a hospital. Another indication is the treatment of adults infected with certain Gram-negative bacteria susceptible to only a limited number of treatment options.

The US Food and Drug Administration approved another combination of ceftazidime/avibactam (Avycaz, Allergan) to treat adults with complicated intra-abdominal or urinary tract infections.

The EMA recommendation of ceftazidime/avibactam now goes to the European Commission, the EU's executive branch, for final approval.

A Help in Home Births

That commission, however, will not take action on the EMA's recommendation of chlorhexidine digluconate to prevent umbilical cord infections. The Committee for Medicinal Products for Human Use rendered its scientific opinion on the antiseptic gel for the sake of regulators in low-income countries outside the EU.

GlaxoSmithKline developed the gel in partnership with Save the Children, a charity based in the United Kingdom.

Guidelines for newborn care from the World Health Organization recommend chlorhexidine for umbilical cord care during home births in regions where neonatal mortality exceeds 30 deaths per 1000 live births. In poorer parts of sub-Saharan Africa and Asia where home births are more common, newborns frequently die of infection after bacteria enter the body through a newly cut umbilical cord, according to a news release from Save the Children. The traditional practice of applying unsterile material such as dung and ash exacerbates the problem.

The United Nations estimates that using chlorhexidine in umbilical cord care could save as many as 422,000 neonatal lives over the course of 5 years.

More information on the EMA recommendations of chlorhexidine digluconate and ceftazidime/avibactam are available on the agency's website.

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