Ceftazidime/Avibactam Designated QIDP for Gram Negative Infections

Forest announced that the FDA has designated its investigational drug, ceftazidime/avibactam, a Qualified Infectious Disease Product (QDIP) for complicated intra-abdominal infections (cIAI), complicated urinary tract infections (cUTI) and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP).

Ceftazidime/avibactam is a combination broad-spectrum cephalosporin (ceftazidime) and a novel beta-lactamase inhibitor (avibactam, formerly NXL104) to treat Gram-negative infections, including extended-spectrum beta-lactamases and Klebsiella pneumoniae carbapenemases that are resistant to existing therapies.

Ceftazidime/avibactam is currently in Phase 3 trials to investigate the efficacy in treating hospitalized patients with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI), both of which are serious Gram-negative bacterial infections.

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