US-based pharmaceutical manufacturer and marketer Forest Laboratories (FRX) has received qualified infectious disease product (QIDP) designation for its ceftazidime/avibactam drug from the US Food and Drug Administration (FDA).
Currently the drug is in Phase III trials to investigate efficacy in treating patients with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI), both serious Gram-negative bacterial infections.
The drug will be used for complicated intra-abdominal infections (cIAI), complicated urinary tract infections (cUTI) and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP).
Forest Laboratories secured rights to ceftazidime/avibactam under a deal with AstraZeneca in December 2009.
The deal involved future co-development and commercialization of two late-stage antibiotic development programs ceftazidime/avibactam and ceftaroline fosamil/avibactam.
The QIDP designation offers certain incentives to the company for carrying out the development of new antibiotics, such as priority review and eligibility for the FDA's fast track program, and a five-year extension of exclusivity under the Hatch-Waxman Act.
The Generating Antibiotic Incentives Now (GAIN) Act, which was part of the FDA Safety and Innovation Act (FDASIA), created the QIDP designation in 2012.
