By Colin Kellaher

Allergan PLC (AGN) on Monday said the U.S. Food and Drug Administration granted fast-track and qualified infectious disease product designations to its ATM-AVI investigational combination antibiotic, which is under development for antibiotic-resistant infections.

The Dublin-based pharmaceuticals company said the designations cover ATM-AVI for the treatment of complicated intra-abdominal infections, complicated urinary tract infections and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia.

The FDA's fast-track program is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The agency's qualified infectious disease product designation provides incentives for the development of new antibiotics, including priority review, eligibility for fast-track designation and a five-year regulatory exclusivity extension.

Allergan and Pfizer Inc. (PFE) are jointly developing ATM-AVI, which is currently in phase III trials. Allergan holds the rights to commercialize ATM-AVI in North America, while Pfizer holds the commercial rights in the rest of the world.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

November 11, 2019 08:05 ET (13:05 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.
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