Merck's Novel Antibiotic Zerbaxa Receives FDA Approval for Treatment of Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia in Adults

On February 12, 2019, the U.S. Food and Drug Administration (FDA) accepted Merck’s supplemental New Drug Application (sNDA) for the combination antibiotic product Zerbaxa (ceftolozane/tazobactam) and granted it Priority Review designation.

VCBeat (WeChat Official Account: vcbeat) learned from foreign media that on June 3, Merck announced that its novel antibiotic, Zerbaxa, had received FDA approval for the treatment of specific bacterial pneumonias in adults, primarily hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP). To mitigate bacterial resistance and preserve the efficacy of other antimicrobial agents, Zerbaxa is currently approved solely for the treatment of confirmed pulmonary infections caused by susceptible bacteria.

Hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) are the second most common healthcare-associated infections in the United States. These conditions are caused by a variety of bacteria, with the Gram-negative pathogen Pseudomonas aeruginosa being the most prevalent. HABP and VABP are difficult to treat and can be fatal in severe cases. According to a recent publication by the NIH Biomarkers Consortium, the mortality rate for mechanically ventilated patients with HABP is approximately 39%, while that for patients with VABP is around 27%.

“Pneumonia in ventilated patients remains a significant clinical challenge, reflecting the considerable morbidity and mortality associated with it,” said Dr. Andrew Shorr, Head of the Department of Pulmonary Medicine at Washington Hospital. “Antibiotic therapy needs to cover a broad spectrum of pathogens, including bacteria such as Pseudomonas aeruginosa, which further complicates the treatment of these infections.”

The newly approved Zerbaxa is a combination antibiotic containing the cephalosporin ceftolozane and the β-lactamase inhibitor tazobactam, which can treat HABP or VABP caused by various pathogens.

During the clinical trials of Zerbaxa, Merck conducted a multicenter, double-blind study (NCT 02070757) on 726 adult patients with HABP/VABP. Patients were administered 3g of Zerbaxa every eight hours for a treatment duration of 8 to 14 days, and the results were compared against the broad-spectrum injectable antibiotic meropenem. The data showed that Zerbaxa demonstrated non-inferiority compared to meropenem, establishing it as a new therapeutic option for this patient population.

Currently, the most common comorbidities in patients taking Zerbaxa include diabetes mellitus, congestive heart failure, and chronic obstructive pulmonary disease, with incidence rates of approximately 22%, 16%, and 12%, respectively.

Notably, Zerbaxa was originally developed by the antibiotic giant Cubist. In late 2014, Merck & Co. acquired Cubist for $9.5 billion, thereby bringing the combination antibiotic Zerbaxa into its portfolio.

Merck, founded in 1891 and headquartered in Whitehouse Station, New Jersey, USA, is one of the world’s largest pharmaceutical companies and a globally recognized leader in healthcare. The company primarily focuses on innovative pharmaceuticals, life sciences, and advanced functional materials technologies. Driven by technology, Merck Group is committed to creating value for patients and customers.

Currently, the company’s business is primarily divided into four major divisions: Merck Serono, Consumer Health, MilliporeSigma, and Performance Materials.

(Compiled by: Wang Chan)