The European Medicines Agency (EMA) has recommended conceding a marketing authorization in the European Union (EU) for Zavicefta (ceftazidime/avibactam), a new treatment against multi-drug resistant bacteria.
Due to lack of availability of medicines to treat patients with infections by resistant bacteria has become a major problem in past years. It is predictable that 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 accepted 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 implicated in bacterial resistance to these antibiotics. By restrain 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, where there is presently an unmet medical need as patients have very few options available due to resistance to treatment.
The medicine is to be used in adult patients with intra-abdominal infection, urinary tract infection, as well as pneumonia acquired in a hospital setting. It is also indicated for the treatment of adult patients with infections caused by certain Gram-negative bacteria, for which there are only restricted treatment options.
The effectiveness of Zavicefta against certain Gram-negative bacteria has been verified in the clinical trials that strengthen the authorization of the indications of intra-abdominal and urinary tract infections, and hospital-acquired pneumonia. The Committee for Medicinal Products for Human use (CHMP) considered that it is helpful to make Zavicefta accessible for patients with infections caused by Gram-negative bacteria, when they have few or no therapeutic options to fight the disease, and suggested to include treatment of these patients in the product information on the basis of a limited set of data.
EMA contributes to the European and global attempt to tackle antimicrobial resistance. A major area of activity is to generate an environment that encourages and facilitates the progress of new antimicrobials.
The outlook adopted by the CHMP at its April 2016 meeting is a conciliator step on Zavicefta’s path to patient access. Once a marketing authorization has been approved, decisions about price and repayment will take place at the level of each Member State, taking into account the potential role of this medicine in the circumstance of the national health system of that country.
Date: 29/04/2016