TUESDAY, SEPTEMBER 27, 2016

Forest Laboratories gains FDA QIDP categorization for drug

Forest Laboratories, Inc., announced on Friday that its investigational drug ceftazidime/avibactam was approved as a qualified infectious disease product by the U.S. Food and Drug Administration.

The FDA created the QIDP categorization as part of its Generating Antibiotic Incentives Now Act in 2012, which incentivized pharmaceutical manufacturers to develop new antibiotics. The QIDP category offers manufacturers incentives, which include priority review, the potential to make the FDA's fast track program and a five-year exclusivity extension, under the Hatch-Waxman Act.

Ceftazidime/avibactam is an investigation drug for the treatment of intra-abdominal infections and complicated urinary tract infections in hospitalized patients; both cIAI and cUTI are serious Gram-negative infections. Ceftazidime/avibactam is in Phase III clinical trials; it has been given the QIDP classification for cIAI, cUTI and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia.

Ceftazidime/avibactam combines a new beta-lactamase inhibitor with a broad cephalosporin to fight against Gram-negative infections that may be resistant to current treatment methods. The drug can also fight against extended-spectrum beta-lactamases and drug-resistant Klebsiella pneumonia carbapenemases.

Forest Laboratories is an international pharmaceutical manufacturer. Through a partnership with AstraZeneca it gained the rights to ceftazidime/avibactam in 2009. Novexel S.A., a branch of AstraZeneca that used to be a French, private infection research company, is responsible for the development of avibactam.

Forest Laboratories currently has a product candidate in a wide variety of therapy areas, all in different stages of clinical trials. It is headquartered in New York City.