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Medicines licensing

EMA recommends approval of antibiotic combination to treat multi-drug resistant bacteria

A new combination antibacterial drug is being recommended for approval in the European Union (EU).

The European Medicines Agency (EMA) proposed on 29 April 2016 that ceftazidime/avibactam, which is being jointly developed by AstraZeneca and Allergan, be given a marketing authorisation as an option for treating multi-drug resistant bacteria.

Although the data to support its authorisation are “limited”, the EMA has decided that the drug should be approved on the grounds that it targets pathogens in areas where treatments are needed.

The drug safety watchdog is recommending ceftazidime/avibactam (Zavicefta) be authorised as a new treatment option for adult patients with intra-abdominal infection, urinary tract infection, as well as hospital-acquired pneumonia. It is also indicated for the treatment of adult patients with infections caused by certain Gram-negative bacteria for which there are only limited treatment options.

It is estimated that Gram-negative bacteria are responsible for two thirds of the annually reported 25,000 deaths resulting from antimicrobial resistance in Europe.

The new intravenous combination product is made up of avibactam, a new beta-lactamase inhibitor, and ceftazidime, a third generation cephalosporin that is already approved for use in the EU.

The EMA says that resistance to cephalosporins and to another class of antibiotics, carbapenems, has been increasing lately, particularly in Gram-negative bacteria, and is of major concern.

The new combination drug works by inhibiting the action of beta-lactamase enzymes, thereby restoring the activity of ceftazidime against ceftazidime-resistant pathogens. It also acts against many of the carbapenem-resistant Enterobacteriaceae.

The recommendation from the EMA’s Committee for Medicinal Products for Human use (CHMP) now goes before the European Commission for approval. It will then be up to individual member states to decide whether to make the drug available within their own health service.

The EMA recommendation comes 14 months after the US Food and Drug Administration approved the same drug combination, marketed as Avycaz, for similar indications.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2016.20201115

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  • The EMA recommends ceftazidime/avibactam for approval

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