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EMA Approves Antimicrobial Resistance Drug

April 29, 2016
Pharmaceutical Technology Editors

The agency recommends the approval of Zavicefta to treat infections caused by resistant bacteria.

On April 29, 2016, the European Medicines Agency (EMA) recommended granting marketing authorization for Zavicefta (ceftazidime/avibactam) for treating patients with infections caused by resistant bacteria. The recommendation by the EMA Committee for Medicinal Products for Human Use (CHMP) will be sent to the European Commission for a decision about whether or not to approve the drug for use across the European Union (EU).

The approval comes as part of a global effort to tackle antimicrobial resistance. EMA estimates that 25,000 patients in the EU die from treatment-resistant bacteria yearly. EMA has been monitoring and analyzing data on antimicrobials to create policy and promote responsible use. A 2013 EMA guidance allows for a flexible approach to developing new antibiotics to fight these resistant pathogens.

Zavicefta treats adults with intra-abdominal infections, urinary tract infections, and pneumonia acquired in a hospital setting. According to EMA, Zavicefta is a fixed combination a new beta-lactamase inhibitor, avibactam, and a third-generation cephalosporins antibiotic, ceftazidime, already approved for use in the EU. Avibactam inhibits beta-lactamases, which are enzymes involved in antibiotic resistance, and restores the activity of ceftazidime against ceftazidime-resistant pathogens. Avibactam also works against many of the carbapenem-resistant Enterobacteriaceae, which is currently an unmet medical need with few treatment options.

It is also used to treat infections caused by Gram-negative bacteria, which also has limited treatment options. EMA states, “the efficacy of Zavicefta against certain Gram-negative bacteria has been demonstrated in the clinical trials that underpin the approval of the indications of intra-abdominal and urinary tract infections, and hospital-acquired pneumonia. CHMP considered that it is beneficial to make Zavicefta available for patients with infections caused by Gram-negative bacteria, when they have few or no therapeutic options to fight the disease, and recommended to include treatment of these patients in the product information on the basis of a limited set of data.”

Source: EMA