EU approves Zinforo (AstraZeneca) for cSSTI and CAP infections

AstraZeneca announced that the European Commission has granted Marketing Authorisation to Zinforo(ceftaroline fosamil), a new intravenous cephalosporin antibiotic, for the treatment of adult patients with complicated Skin and Soft Tissue Infections (cSSTI) or Community Acquired Pneumonia (CAP). This makes Zinforo the only approved cephalosporin monotherapy in Europe with demonstrated clinical efficacy against methicillin-resistant Staphylococcus aureus (MRSA), a common cause of serious and difficult to treat complicated skin infections.

The Marketing Authorization of Zinforo is based on data from the Phase III clinical trial programme which included four pivotal registration trials, CANVAS 1 and 2 (cSSTI) and FOCUS 1 and 2 (CAP). These studies demonstrated consistent clinical efficacy in the treatment of cSSTI and CAP with the recognised tolerability profile of the cephalosporin class. The most common adverse reactions occurring in >/= 3% of patients treated with Zinforo were diarrhoea, headache, nausea, and pruritus and were generally mild or moderate in severity. Zinforo is approved in North America as Teflaro and marketed there by Forest Labs.