Allergan and Pfizer’s Investigational Antibiotic ATM-AVI Receives FDA QIDP and Fast Track Designations for Resistant Gram-Negative Infections

November 19, 2019/Bio ValleyBIOON/-- Allergan recently announced that the U.S. Food and Drug Administration (FDA) has been granted Qualified Infectious Disease Product (QIDP) designation and Fast Track Designation (FTD) for ATM-AVI (aztreonam/avibactam), for the treatment of complicated intra-abdominal infections (cIAI), complicated urinary tract infections (cUTI), and hospital-acquired bacterial pneumonia (HABP)/ventilator-associatedBacteriaVentilator-associated bacterial pneumonia (VABP).

ATM-AVI is an investigational, fixed-dose, intravenous combinationAntibioticsThe product is currently in Phase III clinical development. The drug is developed by Allergan andPfizerJoint development; Allergan holds the commercialization rights for ATM-AVI in North America, while Pfizer holds the commercialization rights in other markets.

ATM-AVI is active against Gram-negative pathogens producing metallo-β-lactamases (MBLs), and currently this class ofBacteriaTreatment options for infection are very limited. Although aztreonam (Aztreonam) is not inactivated by metallo-β-lactamases (MBLs), but its efficacy as a monotherapy is limited because the vast majority of MBL-producing pathogens also express serine-β-lactamases, which can inactivate aztreonam. When combined with avibactam, which inhibits various serine-β-lactamases, the activity of aztreonam against pathogens co-producing MBLs and serine-β-lactamases is restored, thereby providing a new treatment option for patients with such infections.

ATM-AVI (Image source: drugbank.ca)

QIDP is the Qualified Infectious Disease Product designation established under the U.S. FDA Safety and Innovation Act (FDASIA) of July 2012.FDAthe expedited approval pathway for new drugs established under the GIAN Act of the Safety and Innovation Act, aimed at incentivizingAntibioticsR&D to address life-threateningBacteriaInfection. In simple terms, QIDP = Fast Track designation during the research phase + Priority Review during the approval phase + an additional 5 years of market exclusivity post-launch.

Fast Track Designation (FTD) is designed to accelerate drug development and expedite review for serious diseases, addressing significant unmet medical needs in critical areas. An investigational drug receiving Fast Track Designation means that the pharmaceutical company can engage withFDAEngage in more frequent interactions; if relevant criteria are met after submission of the marketing application, eligibility for accelerated approval and priority review is granted, along with eligibility for rolling review.

David Nicholson, Executive Vice President and Chief Research and Development Officer of Allergan, stated: “Globally,”AntibioticsWith the continuous rise in drug resistance rates, patients have limited treatment options when facing these challenging and life-threatening infections, highlighting the need for joint efforts by the pharmaceutical industry and governments to bring forth new potential therapeutic options. The QIDP designation underscores the importance of ATM-AVI in treating serious or life-threatening infections, while the Fast Track designation enables us to collaborate withFDACollaborate more closely to deliver new therapeutic drugs to patients faster.”

Currently, Allergan’s anti-infective product portfolio includes Avycaz (ceftazidime/avibactam), Teflaro (ceftaroline fosamil), Dalvance (dalbavancin), and Monurol (fosfomycin tromethamine).(Bioon.com)

Original Source:ALLERGAN RECEIVES FDA QUALIFIED INFECTIOUS DISEASE PRODUCT (QIDP) DESIGNATION AND FAST TRACK DESIGNATION FOR ATM-AVI (AZTREONAM AND AVIBACTAM) FOR ANTIBIOTIC-RESISTANT GRAM-NEGATIVE INFECTIONS