Yetişkinlerde cilt ve yumuşak doku enfeksiyonlarına karşı geliştirilen bir antibiyotik olan Zinforo Avrupa Komisyonu tarafından onaylandı. (İng)
European regulator clears AstraZeneca’s antibiotic Zinforo
(Ref: Smartmoney, AstraZeneca, FinanzNachrichten)
August 28th, 2012
The European Commission authorised AstraZeneca’s intravenous cephalosporin antibiotic Zinforo (ceftaroline fosamil) for the treatment of adults with complicated skin and soft tissue infections (cSSTI) or community acquired pneumonia (CAP), the company reported Tuesday. The drugmaker noted that the product is “the only approved cephalosporin monotherapy in Europe with demonstrated clinical efficacy against methicillin-resistant Staphylococcus aureus (MRSA).”
In June, Zinforo received a positive recommendation for approval from the European Medicines Agency’s Committee for Medicinal Products for Human Use. AstraZeneca indicated that approval was based on data from four late-stage trials, CANVAS 1 and 2 for cSSTI and FOCUS 1 and 2 for CAP. In the studies, Zinforo showed “consistent clinical efficacy” in the treatment of cSSTI and CAP, including in elderly patients and those with underlying co-morbidities.
AstraZeneca licensed rights to co-develop and commercialise the drug in markets outside the US, Canada and Japan from Forest Laboratories. Last year, Forest launched the drug in the US as a treatment for adults with bacterial pneumonia and drug-resistant skin infections, including MRSA, under the name Teflaro following FDA approval in 2010.