29 April 2016 - Zavicefta is recommended for approval for patients with limited treatment options.

The EMA has recommended granting a marketing authorisation in the EU for Zavicefta (ceftazidime with avibactam), a new treatment option against multi-drug resistant bacteria.

The lack of availability of medicines to treat patients with infections caused by resistant bacteria has become a major problem in recent years. It is estimated that at least 25,000 patients in the EU die each year from infections due to bacteria that are resistant to many medicines.

Zavicefta is a fixed combination of avibactam, a new beta-lactamase inhibitor, and ceftazidime, an antibiotic belonging to the class of third generation cephalosporins that is already approved for use in the EU. Resistance to cephalosporins and to another class of antibiotics, carbapenems, has been increasing lately, in particular in Gram-negative bacteria, and is of major concern. Beta-lactamases are enzymes involved in bacterial resistance to these antibiotics. By inhibiting the action of these enzymes, avibactam restores the activity of ceftazidime against ceftazidime-resistant pathogens. This antibacterial agent also has activity against many of the carbapenem-resistant Enterobacteriaceae, an area where there is currently an unmet medical need as patients have very few options available due to resistance to treatment.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/04/news_detail_002523.jsp&mid=WC0b01ac058004d5c1