Antabio SAS, a private biopharmaceutical company developing novel antibacterial treatments focused on drug-resistant life-threatening infections, announced today that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation to its Metallo Beta-Lactamase Inhibitor ANT2681 in combination with meropenem (MEM) for the treatment of complicated urinary tract infections (cUTI).
The QIDP designation was created by the Generating Antibiotic Incentives Now (GAIN) Act implemented in 2012 to encourage the development of treatments for antibiotic-resistant organisms known to cause serious or life-threatening infections. The QIDP status provides MEM-ANT2681 with a five-year extension of data exclusivity provisions under the Hatch-Waxman Act. The Antabio program is also eligible for Fast Track designation and priority review of its New Drug Application (NDA) for cUTI once submitted.