21 July 2016

AstraZeneca has announced that the results were positive from the Phase III REPROVE trial for Zavicefta (ceftazidime-avibactam), a new combination antibiotic for treating a broad range of serious Gram-negative bacterial infections in hospitalized patients. Zavicefta has been developed in response to the urgent need for new antibiotics for treating serious infections that are increasingly becoming resistant to current antibiotics commonly used for serious infections, such as polymixins and carbapenems, including colistin.

The REPROVE trial evaluated the effectiveness of Zavicefta (ceftazidime-avibactam) compared with meropenem for treating adult patients with hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (ceftazidime-avibactam). Zavicefta met the primary objective of statistical non-inferiority compared to meropenem at the test of cure visit (day 21 from randomisation). Safety observed in the trial was consistent with the known safety profiles of both antibiotics. It is expected that full results from REPROVE will be presented at future scientific meetings.

“The positive results from this important Phase III trial validate our science-led approach and confirm the effectiveness of Zavicefta in treating hospital-acquired pneumonia, providing patients and physicians with a much-needed new treatment option in the fight against antibiotic-resistant pathogens,” said Hans Sijbesma, Managing Director, AstraZeneca Antibiotics Business Unit.

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