FDA Approves Zerbaxa

On Dec. 19, 2014, FDA announced the approval of Zerbaxa (ceftolozane/tazobactam) for the treatment of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI) in adults. The new antibacterial drug product is the fourth to be approved by FDA in 2014 and the fourth to be designated by FDA as a Qualified Infectious Disease Product (QIDP), which is designated by FDA for antibacterial or antifungal human drugs intended to treat serious or life-threatening infections.

As a QIDP-designated drug, Zerbaxa was given priority review, as well as an additional five years of marketing exclusivity to be added to any previously granted exclusivity periods. The efficacy of the drug to treat cIAI was determined through a clinical trial of 979 adults randomly assigned to receive Zarbaxa plus metronidazole or meropenem, an antibacterial drug approved by FDA to treat cIAI. The efficacy of the drug to treat cUTI was determined through a clinical trial of 1068 adults randomly assigned to receive Zerbaxa or levofloxacin, an antibacterial drug approved by FDA to treat cUTI.

Zerbaxa is marketed by recently acquired Cubist Pharmaceuticals. Merck acquired Cubist for $9.5 billion in December 2014, noting that if approved, Zerbaxa would enhance Merck’s “hospital acute care business.” Sivextro, one of the four antibacterial drugs approved by FDA this year, is also a drug marketed by Cubist and is indicated for the treatment of acute bacterial skin and skin structure infections in adults as a result of susceptible isolates of gram-positive microorganisms.

Sources:

FDASivextro