European Commission approves ZINFORO™ (ceftaroline fosamil) for adult patients with serious skin infections or community acquired pneumonia

AstraZeneca today 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*.

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 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™ 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]*. This may help to overcome some of the current treatment challenges faced by physicians when treating this patient population, who require an effective treatment without compromising on tolerability.

“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,” said Martin Mackay, President, R&D, AstraZeneca. “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 Inc. 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.

The European Commission decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on 21 June 2012 and is applicable to all 27 Member States and the three European Economic Area countries of the European Union.

* There is no experience with ZINFORO™ in the treatment in the following patient groups:

• In 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. Caution is advised when treating such patients
• In 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). Caution is advised when treating such patients

** Vulnerable patients with co-morbidities are defined as those:

1. With a reduced ability to fight the infection or tolerate treatment
2. In whom a resistant or difficult to treat pathogen is known or suspected
3. Where there is an urgent need for action

These patients can pose additional treatment challenges for the physician.