Cubist’s experimental antibiotic drug to get priority review from FDA for use in treating several conditions
Federal regulators have granted fast-track review status of several uses for an experimental antibiotic drug developed by Cubist Pharmaceuticals Inc. of Lexington.
The company said it received fast-track status from the Food and Drug Administration for ceftolozane/tazobactam, also known as CXA-201, in treating hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, along with complicated urinary tract infections. In February, the FDA granted fast-track status for CXA-201 in treating complicated intra-abdominal infections.
If the drug is approved under the priority review, Cubist will get a five-year extension of exclusivity under a new antibiotics incentive law signed by President Obama last year.Robert Weisman can be reached at firstname.lastname@example.org. Follow him on Twitter @GlobeRobW.