Pfizer expects to launch Zavicefta in additional markets outside the U.S. throughout 2017 and 2018. Zavicefta was developed in response to the urgent medical need for new antibiotics for difficult-to-treat Gram-negative bacteria, many of which have become increasingly resistant to currently available antibiotics.
In June 2016, the European Medicines Agency (EMA) approved the marketing authorization for Zavicefta based on an extensive clinical trial program. Zavicefta is indicated for the treatment of adults with complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI) and Hospital-Acquired Pneumonia (HAP), including Ventilator Associated Pneumonia (VAP).
Zavicefta is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options. Zavicefta addresses Pseudomonas Aeruginosa and Enterobacteriaceae, two of three “critical” pathogens recently identified by the World Health Organization (WHO). In many markets, existing treatments do not consistently address these resistant pathogens adequately.
University of Udine infectious diseases clinic chief Dr. Matteo Bassetti said: “Multidrug-resistant (MDR) infections are an increasing global threat. The availability of Zavicefta is a major step forward for physicians faced with the challenge of treating patients with known or suspected MDR infections.”
Pfizer executive vice president and chief medical officer Dr. Freda Lewis-Hall said: “The launch of Zavicefta reaffirms Pfizer’s longstanding heritage and commitment to patients facing serious infectious diseases.
“We continue to search for solutions to one of humanity’s most pressing challenges—defeating the microbes that cause infection and misery.”