AstraZeneca’s Zavicefta meets primary endpoint in Phase III pneumonia trials

pharmafile | July 21, 2016 | News story | Research and Development Antibiotics, AstraZeneca, zavifecta 

AstraZeneca has announced results from a Phase III trial for its recently approved antibiotic, Zavicefta (ceftazidime-avibactam), which met its primary endpoints in the treatment of hospital-acquired pneumonia.

Zavicefta was approved by the European Commission last month as a new combination treatment to treat serious Gram-negative bacterial infections that need hospitalisation. The approval of a new antibiotic is significant amid the growing resistance to existing medicines used for serious infections.

In the REPROVE trial, Zavicefta was assessed compared with broad spectrum antibiotic meropenem in the treatment of adult patients with hospital-acquired pneumonia, including ventilator-associated pneumonia.

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The drug met its primary endpoint of statistical non-inferiority compared to meropenum at the test of cure visit (day 21 from randomisation). All-cause mortality rate at day 28 from randomisation was also similar across the two treatment arms.

Hans Sijbesma, MD of AstraZeneca’s antibiotics business unit, says: “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.”

Sean Murray

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