Updated on 29 August 2012
European Commission gives marketing authorization to AstraZeneca for its antibiotic Zinforotm
Singapore: AstraZeneca received marketing authorization for Zinforo (ceftaroline fosamil) by the European Commission. The new intravenous cephalosporin antibiotic can be used for the treatment of adult patients with complicated skin and soft tissue infections (cSSTI) or community acquired pneumonia (CAP).
The authorization makes Zinforo the only approved cephalosporin monotherapy in Europe with demonstrated clinical efficacy against methicillin-resistant Staphylococcus aureus (MRSA), 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 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 less than or equivalent to three percent of patients treated with Zinforo were diarrhoea, headache, nausea, and pruritus, and were generally mild or moderate in severity.
Dr Martin Mackay, president, R&D, AstraZeneca, said that, "We are delighted that Zinforo has received regulatory approval across Europe and believe it will make a valuable contribution to addressing the significant unmet need for new antibiotics. This is a key step in making Zinforo more widely available to patients across the globe and we will work with the appropriate health authorities, formulary and protocol reviews, and clinicians to bring this new antibiotic to patients as soon as possible."
In 2009, Forest Laboratories granted AstraZeneca exclusive worldwide commercial rights and co-exclusive development rights for ceftaroline fosamil, excluding US, Canada and Japan. Forest launched ceftaroline fosamil with similar indications under the trade name Teflaro in the US in March 2011.