Posted by Michael Wonder on 13 Nov 2019
Allergan receives FDA qualified infectious disease product designation and fast track designation for ATM-AVI (aztreonam and avibactam) for antibiotic-resistant gram-negative infections
11 November 2019 - FDA QIDP and fast track designations signify significant milestones in Allergan commitment to addressing unmet medical needs in the treatment of antibiotic resistant infections.
Allergan today announced the U.S. FDA has granted qualified infectious disease product designation and fast track designation for ATM-AVI (aztreonam and avibactam), for the treatment of complicated intra-abdominal infections, complicated urinary tract infections, and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia. ATM-AVI is an investigational, fixed-dose, intravenous combination antibiotic under development globally.
ATM-AVI is being jointly developed with Pfizer. Allergan holds the rights to commercialise ATM-AVI in North America, while Pfizer holds the rights to commercialise this investigational therapy in the rest of the world.
