FDA approves Zerbaxa for hospital-acquired pneumonia

The US Food and Drug Administration today approved a new indication for the previously FDA-approved drug, Zerbaxa (ceftolozane and tazobactam), for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older.

The FDA initially approved US pharma giant Merck & Co’s (NYSE: MRK) Zerbaxa in 2014 to treat complicated intra-abdominal infections and for complicated urinary tract infections. News of the added indication pushed Merck’s share up 1.33% to $80.26 by close of trading on Monday.

“A key global challenge we face as a public health agency is addressing the threat of antimicrobial-resistant infections,” said FDA Principal Deputy Commissioner Dr Amy Abernethy, adding: “Hospital-acquired and ventilator-associated bacterial pneumonia are serious infections that can result in death in some patients. New therapies to treat these infections are important to meet patient needs because of increasing antimicrobial resistance. That’s why, among our other efforts to address antimicrobial resistance, we’re focused on facilitating the development of safe and effective new treatments to give patients more options to fight life-threatening infections.”