The US Food and Drug Administration (FDA) on Friday gave green signal to drug maker Cubist Pharmaceuticals for its experimental antibiotic Zerbaxa to treat complicated intra-abdominal infection (cIAI) and complicated urinary tract infection (cUTI).
This is the second antibiotic approval by the federal agency for the company this year.
The FDA gave its nod to the drug maker after two pivotal Phase III clinical studies showed positive results for its experimental antibiotics.
The trials involved 979 adults. In the first study, the researchers evaluated the efficacy of the drug against cUTI, while they tested the drug against cIAI in the second study.
Both cUTI and cIAI infections are caused by gram-negative bacteria called ‘superbugs’, a class of antibiotic-resistant pathogens.
According to the reports, Zerbaxa met the primary endpoints for two pre-specified medical trials that agreed upon with the federal body and the European Medicines Agency.
The company expects the green signal from EU during the second half of next year. Some of the common side-effects of the drug included diarrhea, nausea and headache.
With the development, Zerbaxa has become the fourth anti-bacterial drug to win FDA’s nod this year. The federal body has given it the status of a qualified infectious disease product (QIDP) under the Generating Antibiotic Incentives Now Act. The status has been awarded to the experimental drug as it belongs to the category of drugs for the treatment of severe forms of infections caused by the superbugs. It is also the fourth drug to be get the QIDP status.