The U.S. Food and Drug Administration on Wednesday approved the use of Actavis Plc’s antibiotic, Avycaz, to battle drug-resistant bacteria known as superbugs.
The drug can be used in combination with generic antibiotic metronidazole to treat adults with complicated intra-abdominal infections. As a standalone medication, it is used to treat urinary tract infections.
Avycaz is a combination of a previously approved antibacterial drug called ceftazidime and avibactam, which protects ceftazidime from being broken down by certain enzymes that are produced by resistant bacteria.
The drug is being co-developed with AstraZeneca Plc.
Significance of approval:
With an eye on the worsening scourge of treatment-resistant bugs, the FDA cleared Avycaz on Phase II data alone, giving Actavis a priority review and indicating the drug only for patients with limited or no other alternatives.
Actavis holds the American rights to Avycaz while AstraZeneca controls the drug in the rest of the world, and the pair are working through Phase III trials set to wrap up this year.
Once they have late-stage data, Actavis will hand it into the FDA in hopes of expanding the drug’s label, and AstraZeneca will use it to support global approvals.
Head on with Zerbaxa:
Now Avycaz will contend with Merck’s recently approved Zerbaxa (ceftolozane and tazobactam), which also combines a cephalosporin with a beta-lactamase inhibitor.
Zerbaxa (ceftolozane and tazobactam) is a cephalosporin and beta-lactamase inhibitor combination for the treatment of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).
As market potential and expectation sales of Zerbaxa expected to be $1 Billion a year.
Zerbaxa NDA was submitted in April, 2014 and got approval by December, 2014.