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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.”