The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application for tebipenem HBr (tebipenem pivoxil hydrobromide) for the treatment of adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible microorganisms.
Tebipenem HBr is an investigational oral antibiotic in the carbapenem class. The application includes data from the multicenter, randomized, double-blind, double-dummy phase 3 ADAPT-PO trial (ClinicalTrials.gov Identifier: NCT03788967), which evaluated the efficacy and safety of tebipenem HBr in 868 adults with cUTI or acute pyelonephritis. Findings showed that treatment with tebipenem HBr was statistically noninferior to ertapenem with respect to overall response (combined clinical cure plus microbiological eradication) at the test-of-cure visit in the microbiological-intent-to-treat population.
“If approved, tebipenem HBr may provide patients an oral treatment option, allowing them to potentially either recover at home from their infections or leave the hospital sooner,” said Ankit Mahadevia, MD, CEO of Spero. “[…] We are committed to working closely with the FDA throughout the NDA review process and look forward to tebipenem HBr’s anticipated launch in the second half of 2022.”
A Prescription Drug User Fee Act (PDUFA) target date of June 27, 2022 has been set for the application. The FDA previously granted Qualified Infectious Disease Product (QIDP) and Fast Track designations to tebipenem HBr for these cUTI indications.
Spero Therapeutics announces FDA acceptance and Priority Review of New Drug Application for tebipenem HBr for the treatment of complicated urinary tract infections including pyelonephritis. News release. Spero Therapeutics, Inc. January 3, 2022. https://www.globenewswire.com/news-release/2022/01/03/2360040/0/en/Spero-Therapeutics-Announces-FDA-Acceptance-and-Priority-Review-of-New-Drug-Application-for-Tebipenem-HBr-for-the-Treatment-of-Complicated-Urinary-Tract-Infections-including-Pyelon.html.