FDA accepts new drug application for ceftolozane/tazobactam
Cubist Pharmaceuticals Inc. recently announced that the FDA has accepted the company’s new drug application for its novel combination antibiotic ceftolozane/tazobactam with priority review.
Cubist is seeking FDA approval of the antibiotic for the treatment of complicated urinary tract infections and complicated intra-abdominal infections.
The new drug application is based on results from two phase 3 clinical trials of ceftolozane/tazobactam, which demonstrated activity against several gram-negative pathogens causing UTIs and intra-abdominal infections in adult patients. These included Pseudomonas aeruginosa, extended-spectrum beta-lactamase–producing Escherichia coli and Klebsiella pneumoniae.
Under the Generating Antibiotic Incentives Now (GAIN) Act, the FDA designated the antibiotic as a qualified infectious disease product (QIDP) in 2013, making it eligible for fast track status and priority review. QIDP status also gives Cubist a 5-year extension of product exclusivity if the drug is ultimately approved by the FDA.
“We are pleased that the FDA accepted the [new drug application] with priority review for ceftolozane/tazobactam,” Steven Gilman, PhD, executive vice president of research and development and chief scientific officer of Cubist, said in a press release. “We look forward to working with the FDA on the review, and hope to bring this potential new treatment option to physicians and their patients to address resistant gram-negative infections.”