FDA green lights combination antibiotic

FDA approved ceftolozane/tazobactam (Zerbaxa, Cubist Pharmaceuticals, Inc.) for the treatment of adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by designated susceptible Gram-negative bacteria. 

Gram-negative bacteria are common causes of cIAIs and cUTIs.

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The approval of Zerbaxa was supported by positive data from 2 pivotal phase 3 clinical trials-1  in patients with cUTI and the other in patients with cIAI. Both trials met the pre-specified primary end points agreed upon FDA and European Medicines Agency (EMA). 

Zerbaxa is the first new antibiotic approved in the United States under the Generating Antibiotic Incentives Now (GAIN) Act to treat Gram-negative bacteria. Zerbaxa is designated by 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. The QIDP designation qualifies Zerbaxa for certain incentives related to the development of new antibiotics, including a five year extension of Hatch-Waxman exclusivity. Zerbaxa is Cubist’s second antibiotic that has received FDA approval this year, marking the first time this century a company has delivered 2 new FDA-approved antibiotics in a single year.

“Physicians view the ability to treat Gram-negative infections as a high unmet need,” said Steve Gilman, PhD, executive vice president, research & development and chief scientific officer, Cubist Pharmaceuticals. “There has been a need for new treatments to address the rising resistance of Gram-negative bacteria.  We see Zerbaxa meeting a need a new option for physicians to address certain designated susceptible Gram-negative bacteria where few treatment options exist.”

Generally, with resistant bacterial infections resulting in an estimated 25,000 deaths in the European Union and 23,000 deaths in the United States annually, the issues of rising antibiotic resistance and the lack of treatment options have raised worldwide concern.

“Specifically in the area of Gram-negative infections, due to rising resistance rates of traditional first-line agents, options have been limited,” Gilman told FormularyWatch. “Additionally, organizations, such as the [CDC], have expressed concern about the overuse of antibiotics, such as carbapenems, and the need to reserve these antibiotics, which are considered last resort agents-stressing the importance of using the right therapy at the right time to help control the spread of resistant bacteria.

“By having new options to treat patients with these resistant pathogens, clinical value can be demonstrated and economic value may be able to be realized by limiting the consequences of inappropriate therapy using antibiotics to which the pathogen is resistant,” he continued.

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Zerbaxa will serve a different purpose from other antibiotics in the treatment continuum and as part of a stewardship approach, using the right drug for the right patient, at the right time, at the right dose and duration, according to Gilman.