Aztreonam + Avibactam Combo Therapy Granted QIDP, Fast Track Status for Antibiotic-Resistant Infections

The Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation and Fast Track designation to ATM-AVI (aztreonam and avibactam; Allergan) for the treatment of complicated intra-abdominal infections (cIAI), complicated urinary tract infections (cUTI), and hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP). 

Aztreonam is a monobactam that has activity against metallo β-lactamase (MBL)-producing Gram-negative pathogens. Although aztreonam is bactericidal against MBL, these pathogens commonly express serine-β-lactamases that can inactivate aztreonam. Thus, the combination with avibactam inhibits the serine-β-lactamases and allows aztreonam to work against MBL-producing pathogens.

The Company is currently investigating ATM-AVI in phase 3 trials as a fixed-dose, intravenous combination therapy.

“The rate of antibiotic resistance is increasing worldwide and there are limited options available to patients with these challenging and life-threatening infections, underscoring the need for the pharmaceutical industry and government to work together to bring forward new potential treatment options,” said David Nicholson, EVP and Chief R&D Officer, Allergan. “The QIDP Designation shows the importance of ATM-AVI for treating serious or life-threatening infections, and the Fast Track Designation allows us to work even closer with the FDA to bring patients a new treatment faster.”

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