FDA approves Zerbaxa for treatment of cUTI and cIAI Infections- Cubist Pharma/Merck Inc.

Cubist Pharmaceuticals, Inc. announced that the FDA approved Zerbaxa (ceftolozane/tazobactam) for the treatment of adults with Complicated Urinary Tract Infections (cUTI) and Complicated Intra-Abdominal Infections (cIAI) caused by designated susceptible Gram-negative bacteria. The approval of Zerbaxa was supported by positive data from two pivotal Phase III clinical trials—one in patients with cUTI and the other in patients with cIAI. Both trials met the pre-specified primary endpoints agreed upon with the FDA and European Medicines Agency (EMA).

Zerbaxa is the first new antibiotic approved in the U.S. under the Generating Antibiotic Incentives Now (GAIN) Act to treat Gram-negative bacteria. Zerbaxa is designated by the FDA as a Qualified Infectious Disease Product (QIDP) for its indications, according to the GAIN Act. The GAIN Act provides incentives to develop new antibacterial drugs for the treatment of serious or life-threatening disease or condition caused by drug resistant pathogens.