Oral Taibipenem HBr Receives Priority Review Qualification for Treatment of Complicated Urinary Tract Infections_ Kanghule

Introduction: Complicated urinary tract infection (cUTI) refers to a urinary tract infection that is accompanied by a risk of infection or treatment failure, such as structural or functional abnormalities of the genitourinary tract, or other underlying diseases. Recently, the FDA granted priority review status to Taibipenem HBr to treat this disease.

On November 4, 2021, the U.S. Food and Drug Administration (FDA) granted priority review status for the New Drug Application for terbipenem HBr (terbipenem hydrobromide) for the treatment of adults with complicated urinary tract infections (cUTI) caused by susceptible microorganisms, including pyelonephritis.

Taibipenem HBr is an investigational oral antibiotic of the carbapenem class. The application is based on data from the multicenter, randomized, double-blind, double-prosthesis Phase 3 ADAPT-PO trial (NCT03788967), which evaluated the efficacy and safety of Taibipenem HBr in 868 adults with cUTI or acute pyelonephritis.

The results showed that in the microbiologically treated population, HBr treatment with terbipenem was statistically non-inferior to ertapenem in terms of overall response (combined clinical cure and microbial eradication) at the time of cure trials.

Dr. Ankit Mahadevia, CEO of Spero, said: "If approved, Taibipenem HBr may provide patients with a new oral treatment option, making it possible for them to recover faster or leave the hospital earlier. We will work closely with the FDA throughout the NDA review process, and Taibipenem HBr is expected to be available in the second half of 2022."

The Prescription Drug User Fee Act (PDUFA) target date is June 27, 2022. The FDA previously granted Taibipenem HBr Qualified Infectious Disease Product (QIDP) and Fast Track designations for these cUTI indications.

References:

https://www.empr.com/home/news/drugs-in-the-pipeline/tebipenem-hbr-gets-priority-review-for-oral-treatment-of-complicated-uti/