Cubist antibiotic regimen gets fast-track review
Cubist says antibiotic regimen will get a fast-track review as a treatment for 3 infections
LEXINGTON, Mass. (AP) -- Cubist Pharmaceuticals Inc. said Tuesday that the Food and Drug Administration has given fast-track status to an experimental antibiotic regimen as a treatment for three types of infections.
The company is studying a combination of ceftolozane and tazobactam as a treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia as well as complicated urinary-tract infections. In February, the FDA granted fast-track status for the drug regimen as a treatment for complicated intra-abdominal infections.
Fast-track status gives companies extra meetings and correspondence with regulators throughout the review process, and it allows the drugmaker to submit data as it compiles it.
Cubist gets most of its revenue from Cubicin, a treatment for skin infections like the MRSA "superbug" and blood infections.
The company's shares shed 13 cents to $47.48 in afternoon trading. They are up 13 percent for 2013.
