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Zerbaxa approved for hospital acquired bacterial pneumonia

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DINSDAY June 11, 2019 (HealthDay News) – Zerbaxa (ceftolozane and tazobactam) has been approved for a new indication for the treatment of hospital-acquired bacterial pneumonia and respiratory-related bacterial pneumonia (HABP / VABP) in patients 18 years and older, announced the US Food and Drug Administration yesterday.

In 2014, the FDA approved Zerbaxa for the first time for the treatment of complicated intra-abdominal infections and urinary tract infections. According to the manufacturer's prescribing information, Zerbaxa is administered in a recommended dosing schedule of 1.5 g injection every eight hours by intravenous infusion for one hour. Duration of treatment should be based on the site of infection and the severity and progress of the patient.

In a multinational, double-blind study of 726 patients admitted to hospital with HABP / VABP and injected with Zerbaxa or another antibacterial drug, researchers found similar mortality and cure rates between the two drugs. The most commonly reported adverse reactions in patients treated with Zerbaxa include elevated liver enzyme levels, renal insufficiency or failure and diarrhea.

The FDA notes that Zerbaxa should not be used in patients known to have severe hypersensitivity to the components of the drug or to piperacillin / tazobactam or other antibacterial drugs in the beta-lactam class.

Approval from Zerbaxa for this new indication has been granted to Merck and Co.

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