Iterum Therapeutics Faces FDA Hurdles with Sulopenem Application

Key Insights

• The FDA has identified deficiencies in Iterum Therapeutics' sulopenem etzadroxil/probenecid application for uncomplicated urinary tract infections, delaying potential approval.
• The deficiencies preclude discussions on labeling and post-marketing commitments, according to the FDA's communication to Iterum.
• Iterum intends to collaborate with the FDA to address and resolve the identified deficiencies before the goal date of July 25.

Iterum Therapeutics plc (NASDAQ: ITRM) is facing regulatory challenges as the FDA has flagged deficiencies in its marketing application for sulopenem etzadroxil/probenecid. The drug is intended for the treatment of uncomplicated urinary tract infections (uUTIs). The FDA communicated these issues to Iterum in a letter, stating that the identified deficiencies currently prevent discussions regarding labeling and post-marketing requirements.

The specific details of the deficiencies were not disclosed by the FDA in its notification. However, the agency clarified that this notification does not represent a final decision on the application. The FDA has set a goal date of July 25 for the completion of its review of the New Drug Application (NDA).

Iterum Therapeutics has stated its intention to work closely with the FDA to fully understand the nature of the deficiencies and to address and resolve them as quickly as possible. The company aims to secure approval for sulopenem, which is poised to address a significant unmet need in the treatment of uUTIs, particularly those resistant to commonly prescribed antibiotics. The successful resolution of these issues is critical for Iterum to meet its regulatory and commercial objectives.