FDA Granted Qualified Infectious Disease Product and Fast Track Designation for ATM-AVI


Allergan plc announced the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) Designation and Fast Track Designation for ATM-AVI (aztreonam and avibactam), 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). ATM-AVI is an investigational, fixed-dose, intravenous combination antibiotic under development globally.

“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.”

The QIDP designation provides certain incentives for the development of new antibiotics, including priority review and eligibility for the FDA’s Fast Track Designation, and a five-year regulatory exclusivity extension. The Fast Track Designation is designed to facilitate the development, and accelerate the review of drugs to treat serious conditions that do not have sufficient treatment options.

ATM-AVI has activity against metallo β-lactamase (MBL)-producing Gram-negative pathogens, for which there are currently very limited treatmentoptions. Although aztreonam is not inactivated by metallo beta-lactamases (MBLs), as a single agent it has limited utility because the vast majority of MBL-producing pathogens also express serine-β-lactamases that can inactivate it. When combined with avibactam’s ability to inhibit many serine-β-lactamases , aztreonam’s activity is restored against pathogens that co-produce MBLs and serine enzymes, thus presenting a new treatment for patients with these infections. ATM-AVI is currently in Phase III trials.

ATM-AVI is being jointly developed with Pfizer. Allergan holds the rights to commercialize ATM-AVI in North America, while Pfizer holds the rights to commercialize this investigational therapy in the rest of the world.

ATM-AVI is a drug candidate under development and supported by public-private partnerships between Pfizer and the Biomedical Advanced Research and Development Authority (BARDA)*, and between Pfizer and the European Union’s Innovative Medicines Initiative (IMI) – a partnership between the European Union and the European pharmaceutical industry, under a project called COMBACTE-CARE (Combating Bacterial Resistance in Europe – Carbapenem Resistance)**. Allergan’s anti-infective portfolio also includes AVYCAZ ® (ceftazidime and avibactam), TEFLARO ® (ceftaroline fosamil), DALVANCE ® (dalbavancin) and MONUROL ® (fosfomycin tromethamine).