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AstraZeneca’s antibiotic Zavicefta show positive results in Phase III trial

 

Clinical courses

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

The REPROVE trial assessed the efficacy of Zavicefta (ceftazidime-avibactam) compared with meropenem in the treatment of adult patients with hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP). Zavicefta met the primary objective of statistical non-inferiority compared to meropenem at the test of cure visit (day 21 from randomisation). All-cause mortality rate at day 28 from randomisation was also similar in the two groups. Safety observed in the trial was consistent with the known safety profiles of both antibiotics. Full results from REPROVE are expected to be presented at future scientific meetings.

Hans Sijbesma, Managing Director, AstraZeneca Antibiotics Business Unit, said: “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.”

On 24 June 2016, Zavicefta was approved by the European Commission for intravenous use in the treatment of adult patients suffering from HAP, including VAP, as well as: Complicated intra-abdominal infections (cIAI); complicated urinary tract infections (cUTI), including pyelonephritis; and the treatment of aerobic Gram-negative infections in adult patients who have limited treatment options.

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