Cubist Gets FDA Approval Of New Antibiotic Zerbaxa

(RTTNews) - Cubist Pharmaceuticals, Inc. (CBST) said Friday that the U.S. Food and Drug Administration has approved Zerbaxa for the treatment of adults with complicated urinary tract infections and complicated intra-abdominal infections caused by designated susceptible Gram-negative bacteria.

The approval of Zerbaxa was supported by positive data from two pivotal Phase 3 clinical trials—one in patients with complicated urinary tract infections and the other in patients with complicated intra-abdominal infections. Both trials met the pre-specified primary endpoints agreed upon with the FDA and European Medicines Agency.

Zerbaxa is the first new antibiotic approved in the U.S. under the Generating Antibiotic Incentives Now (GAIN) Act to treat Gram-negative bacteria. Also, Zerbaxa is Cubist's second antibiotic that has received FDA approval this year.