FX.co ★ Iterum Therapeutics Says FDA Determines To Take NDA For Sulopenem To Advisory Committee

Pharmaceutical company Iterum Therapeutics plc (ITRM) announced on Friday that the U.S. Food and Drug Administration (FDA) will refer the New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem), intended for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women, to an Advisory Committee.

In its communication, the FDA emphasized that the Advisory Committee's discussions will focus on two key points: first, antimicrobial stewardship issues that could arise from the potential approval and subsequent use of what would be the first oral penem in the U.S.; and second, identifying the most appropriate target patient populations for the treatment of uUTI with sulopenem etzadroxil/probenecid.

The Advisory Committee meeting is tentatively scheduled for September 9, 2024.