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AstraZeneca PLC's ZINFORO Receives Positive Chmp Opinion In European Union For Treatment Of Patients With Serious Skin Infections Or Community Acquired Pneumonia


Friday, 22 Jun 2012 07:30am EDT 

AstraZeneca PLC announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of 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). The CHMP's positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. The CHMP reviewed data from the Phase III clinical trial programmes which included four pivotal registration trials, CANVAS 1 and 2 (cSSTI) and FOCUS 1 and 2 (CAP). Clinical data demonstrated that Zinforo was effective and well tolerated in adult patients (≥18 years of age) with cSSTI or CAP, including those patients with underlying co-morbidities. Complicated Skin and Soft tissue Infections (cSSTI) are difficult-to-treat infections of the skin and underlying soft tissues such as fascia and muscle layers e.g. deep soft tissue abscesses, cellulitis and surgical site infections. 

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