Drugs Xagena
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 ).
Zinforo is 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.
Zinforo was designed to be different from previously approved cephalosporins and has a novel mode of action which results in bactericidal activity and broad coverage against common causative pathogens, such as Staphylococcus aureus, including MRSA, and Streptococci in cSSTI and Streptococcus pneumoniae and Methicillin-susceptible Staphylococcus aureus ( MSSA ) in CAP.
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 have 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 greater than or equal to 3% of patients treated with Zinforo were diarrhoea, headache, nausea, and pruritus and were generally mild or moderate in severity.
Zinforo has also demonstrated clinical efficacy in vulnerable patient groups, for example the elderly, or those with underlying comorbidities ( such as diabetes mellitus or peripheral vascular disease in cSSTI or chronic obstructive pulmonary disease [ COPD ] or asthma in CAP ].
There is no experience with Zinforo in the treatment in the following patient groups: A) cSSTI: the immunocompromised, patients with severe sepsis/septic shock, necrotising fasciitis, perirectal abscess and patients with third degree and extensive burns. There is limited experience in treating patients with diabetic foot infections; B) CAP: immunocompromised; patients with severe sepsis/septic shock, severe underlying lung disease; patients with PORT Risk Class V, and/or CAP requiring ventilation at presentation, CAP due to MRSA; patients requiring intensive care; the available clinical data cannot substantiate efficacy against penicillin non-susceptible strains of Streptococcus pneumoniae ( PNSP ). ( Xagena )
Source. AstraZeneca, 2012
XagenaMedicine_2012
