FDA approvals

FDA approves Zerbaxa for complicated intra-abdominal infections, UTIs

The FDA has approved a new combination antibiotic for the treatment of complicated intra-abdominal infections and complicated urinary tract infections in adults.

Ceftolozane/tazobactam (Zerbaxa, Cubist) contains a cephalosporin and a beta-lactamase inhibitor. Used alone, it can treat complicated UTIs, including pyelonephritis. It can also be used in combination with metronidazole to treat complicated intra-abdominal infections

Zerbaxa is the fourth antibiotic approved by the FDA this year. It follows dalbavancin (Dalvance, Durata Therapeutics), tedizolid (Sivextro, Cubist) and oritavancin (Orbactiv, The Medicines Company). All four were designated as qualified infectious disease products under the Generating Antibiotic Incentives Now (GAIN) Act, which allowed for priority, expedited review.

“The FDA approval of several new antibacterial drugs this year demonstrates the agency’s commitment to increasing the availability of treatment options for patients and physicians,” Edward Cox, MD, MPH, director of the FDA’s Office of Antimicrobial Products, said in a press release. “We must continue to help foster the development of new antibacterial drugs and encourage prudent use of existing treatments to conserve their utility.”

Edward Cox

Edward Cox

Zerbaxa demonstrated efficacy against complicated intra-abdominal infections in a clinical trial of 979 adults who were randomly assigned Zerbaxa and metronidazole or meropenem. In complicated UTIs, Zerbaxa demonstrated efficacy in a clinical trial of 1,068 patients who were randomly assigned Zerbaxa or levofloxacin.

The most common adverse effects associated with Zerbaxa included nausea, diarrhea, headache and fever. The label will include a warning about decreased efficacy observed among patients with renal impairment.

The Infectious Diseases Society of American said in a statement that the approval of Zerbaxa represents the halfway point to the goal outlined in its 10 x ’20 initiative, 10 new systemic antibacterial drugs by 2020. Zerbaxa also is the first of the five antibiotics to address gram-negative bacteria.

“But even this important approval doesn’t address all of our antibiotic needs,” IDSA said in the statement. “Patients still face life-threatening infections for which additional new antibiotics are urgently needed. IDSA will continue to advocate for economic and regulatory incentives to help bring these new antibiotics to market, and for improved stewardship, data collection and diagnostics to ensure antibiotics are used appropriately.”

The FDA has approved a new combination antibiotic for the treatment of complicated intra-abdominal infections and complicated urinary tract infections in adults.

Ceftolozane/tazobactam (Zerbaxa, Cubist) contains a cephalosporin and a beta-lactamase inhibitor. Used alone, it can treat complicated UTIs, including pyelonephritis. It can also be used in combination with metronidazole to treat complicated intra-abdominal infections

Zerbaxa is the fourth antibiotic approved by the FDA this year. It follows dalbavancin (Dalvance, Durata Therapeutics), tedizolid (Sivextro, Cubist) and oritavancin (Orbactiv, The Medicines Company). All four were designated as qualified infectious disease products under the Generating Antibiotic Incentives Now (GAIN) Act, which allowed for priority, expedited review.

“The FDA approval of several new antibacterial drugs this year demonstrates the agency’s commitment to increasing the availability of treatment options for patients and physicians,” Edward Cox, MD, MPH, director of the FDA’s Office of Antimicrobial Products, said in a press release. “We must continue to help foster the development of new antibacterial drugs and encourage prudent use of existing treatments to conserve their utility.”

Edward Cox

Edward Cox

Zerbaxa demonstrated efficacy against complicated intra-abdominal infections in a clinical trial of 979 adults who were randomly assigned Zerbaxa and metronidazole or meropenem. In complicated UTIs, Zerbaxa demonstrated efficacy in a clinical trial of 1,068 patients who were randomly assigned Zerbaxa or levofloxacin.

The most common adverse effects associated with Zerbaxa included nausea, diarrhea, headache and fever. The label will include a warning about decreased efficacy observed among patients with renal impairment.

The Infectious Diseases Society of American said in a statement that the approval of Zerbaxa represents the halfway point to the goal outlined in its 10 x ’20 initiative, 10 new systemic antibacterial drugs by 2020. Zerbaxa also is the first of the five antibiotics to address gram-negative bacteria.

“But even this important approval doesn’t address all of our antibiotic needs,” IDSA said in the statement. “Patients still face life-threatening infections for which additional new antibiotics are urgently needed. IDSA will continue to advocate for economic and regulatory incentives to help bring these new antibiotics to market, and for improved stewardship, data collection and diagnostics to ensure antibiotics are used appropriately.”