Anglo-Swedish drugs developer AstraZeneca said its Zinforo skin infection treatment has been given a positive verdict by the Committee for Medicinal Products for Human Use (CHMP).
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 (relating to complicated Skin and Soft Tissue Infections, or cSSTI) and FOCUS 1 and 2 (relating to Community Acquired Pneumonia, or CAP). Clinical data demonstrated that Zinforo was effective and well tolerated in adult patients with cSSTI or CAP, including those patients with more than one underlying disorder.
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"We remain one of the few companies still committed to novel antibiotic research, with one of the world's largest antibacterial pipelines and many strong partnerships to address this significant unmet medical need," noted Martin Mackay, President of Research & Development at Astra.
Astra has been granted exclusive commercial rights and co-exclusive development rights for ceftaroline fosamil (.i.e Zinforo) by Forest Labs for all countries except the USA, Canada and Japan.
AstraZeneca has made regulatory submissions in a number of countries where it has commercialisation rights and further submissions are planned in 2012.
JH
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