FDA Accepts Resubmission of NDA for Oral Sulopenem in Uncomplicated UTIs
Key Insights
The FDA has accepted Iterum Therapeutics (search)' resubmitted New Drug Application (NDA) for oral sulopenem for treating uncomplicated urinary tract infections (search) (uUTIs).
The FDA has granted a Prescription Drug User Fee Act (PDUFA) action date of October 25, 2024, for oral sulopenem.
The resubmission includes data from the REASSURE clinical trial, which demonstrated oral sulopenem's non-inferiority and statistically significant superiority compared to Augmentin®.
Iterum Therapeutics (search) plc announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (search) (uUTIs) in adult women. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of October 25, 2024.
REASSURE Trial Data
The resubmission incorporates additional evidence from the REASSURE (REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales) clinical trial. This trial compared oral sulopenem to oral Augmentin® in adult women diagnosed with uUTIs. The results demonstrated that oral sulopenem was non-inferior to Augmentin® regarding the primary efficacy endpoint, which assessed clinical and microbiologic response at the test-of-cure visit for patients with an Augmentin®-susceptible pathogen. Furthermore, the overall success rate showed statistically significant superiority for oral sulopenem compared to Augmentin®.
Management Commentary
"We are very pleased that the FDA has accepted the resubmission of the NDA for oral sulopenem," said Corey Fishman, Chief Executive Officer. "This significant milestone brings us one step closer to the potential approval of oral sulopenem for uUTIs providing patients and physicians with a much-needed treatment option for this underserved market. We look forward to continuing to work with the FDA during its review."
About Sulopenem
Sulopenem is a novel penem anti-infective compound in Phase 3 clinical development with both oral and IV formulations. It has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive, and anaerobic bacteria resistant to other antibiotics. Iterum Therapeutics (search) has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for both oral and IV formulations of sulopenem in seven indications.