Swissmedic, the Swiss agency for therapeutic products, has approved Zevtera (ceftobiprole medocaril) for the treatment of complicated skin and soft tissue infections, including diabetic foot infections which have not spread to the bone.
Ceftobiprole is licensed from and co-developed with Basilea Pharmaceutica Ltd. Janssen-Cilag will market ceftobiprole in Switzerland under the trade name Zevtera. Swiss based Basilea Pharmaceutica Ltd will co-promote the drug in key European markets and North America.
Ceftobiprole is the first, broad-spectrum, anti-MRSA cephalosporin antibiotic with activity against a range of difficult-to-treat Gram-positive and Gram-negative hospital- and community-acquired pathogens including methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa. In clinical trials, ceftobiprole has demonstrated high cure rates in patients with complicated skin infections, including those caused by the potentially deadly MRSA.
Data from the European Antimicrobial Resistance Surveillance System (EARSS) show that the prevalence of MRSA - a difficult to treat cause of hospital-and- community acquired infections - while varying considerably among countries, has been rising across Europe for the past six years.
The use of ceftobiprole in adults for the treatment of complicated soft tissue infections, including diabetic foot infections which have not spread to the bone, is under regulatory review in United States, Australia and in the European Union among other countries. In Canada, ceftobiprole was launched in August 2008 under the trade name Zevtera.
Complicated skin and soft tissue infections are among the most common infections in the hospital setting. Staphylococcus aureus is the predominant pathogen in these infections. In recent years, resistant strains, such as MRSA have become increasingly common and have been associated with increased morbidity and mortality. New broad-spectrum antibiotics that cover resistant bacteria such as MRSA, but also clinically important and problematic Gram-negative pathogens, address a high-unmet medical need in the treatment of severe skin and soft tissue infections.
Patients with chronic wounds or those who have recently received antibiotics may also be infected by Gram-negative pathogens. This is frequently the case for diabetic patients with foot infections. Adequate treatment of diabetic foot infections can require hospitalization, surgery and broad-spectrum intravenous antibiotics.