Achaogen Inc. is seeking European approval of Zemdri, a drug to treat resistant bacteria, after announcing a corporate restructuring to develop the medicine in July.
The South San Francisco, Calif.-based biotechnology company has submitted an application to the European Medicines Agency for Zemdri, or plazomicin, to treat certain infections. The drug is targeting complicated urinary tract infections including kidney infection pyelonephritis, bloodstream infections due to certain gram-negative bacteria known as Enterobacteriaceae, and infections due to Enterobacteriaceae in adult patients with limited treatment options.
The drug, which is given by intravenous infusion, can be used to treat multidrug-resistant, gram-negative pathogens such as those arising from the Enterobacteriaceae class of organisms that include E. coli, salmonella and shigella, bacteria which the U.S. Centers for Disease Control have classified as urgent and serious public health threats.
Achaogen said the marketing authorization application is based on data from two studies known as Epic and Care. In the phase 3 trial Epic, Zemdri worked as well as Pfizer Inc. antibiotic Merrem, also known as meropenem, to treat complicated urinary tract infections.
Zemdri was approved in June by the U.S. Food and Drug Administration to treat patients with complicated urinary tract infections, but the drug was rejected by the agency for treating bloodstream infections because data from the Care clinical study did not prove Zemdri's effectiveness.
In July, the biotechnology company said it would lay off about 80 workers in a corporate restructuring to focus its resources on the commercialization of Zemdri in the U.S. and on an EU filing for the drug.
To develop Zemdri, the company received funding from the Biomedical Advanced Research and Development Authority, which operates under the U.S. Department of Health and Human Services and provides support for research and development, acquisition and manufacturing infrastructure for vaccines, drugs and diagnostic tools for public health emergency threats.