The FDA approved Zerbaxa June 3 for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.
Zerbaxa, a combination of cephalosporin ceftolozane and tazobactam, was initially approved in 2014 to treat intra-abdominal infections and complicated urinary tract infections.
The new indication for the drug, given by injection, was demonstrated in a double-blind study that compared the drug to another antibacterial drug. Mortality and cure rates for Zerbaxa were similar to the treatment used as a comparison.
Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia are life-threatening pulmonary infections that often affect already vulnerable patients. They are also the second most common type of hospital-acquired infection in the U.S.
Zerbaxa is manufactured by Merck.