FDA approves Cubist's novel antibiotic Zerbaxa for complicated infections
- Zerbaxa (ceftolozane and tazobactam), developed by Cubist, is intended to treat complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI) in adults.
- Zerbaxa is the fourth new FDA-approved antibiotic that is designated as a Qualified Infectious Disease Product (QIDP) this year.
- Zerbaxa is intended to be used with metronidazole for treatment of cIAI and as monotherapy for treatment of cUTI.
Given the proliferation and virulence of multi-drug resistant, pathogen-driven infections, the current focus on developing and approving new antibiotics is a good sign that things are moving in the right direction.
Efficacy of Zerbaxa for treatment of cUTI was established in a pool of 1,068 patients, while Zerbaxa's efficacy (in combination with metronidazole) in treatment of cIAI was established in a group of 979 patients—a sufficiently large population on which to base an approval for this type of antibiotic.
The approval should also let pharma giant Merck, which struck a $9.5 billion deal to buy Cubist earlier this month, breathe a sigh of relief. A federal judge invalidated four of the five patents for Cubist's top-selling drug, Cubicin, just one day after the Merck deal was announced, raising fears that the company had significantly overpaid for its acquisition. A major new approval like Zerbaxa's is likely to reassure shareholders.