Spero Therapeutics, Inc. announced that the U.S. Food and Drug Administration has granted Priority Review designation and confirmed the acceptance for substantive review of the New Drug Application seeking approval for tebipenem HBr oral tablets for treatment in adult patients with complicated urinary tract infections, including acute pyelonephritis, caused by susceptible microorganisms. Tebipenem HBr has been granted Qualified Infectious Disease Product, Fast Track, and Priority Review designations for these cUTI indications. The Agency is planning to hold an Advisory Committee meeting to discuss this application and has also set a Prescription Drug User Fee Act target action date of June 27, 2022. The NDA submission includes previously communicated positive data from the Phase 3 ADAPT-PO trial.

These data showed that ADAPT-PO met its primary endpoint by demonstrating that oral tebipenem HBr was statistically non-inferior to intravenous ertapenem in the treatment of patients with cUTI and patients with acute pyelonephritis.