Iterum Therapeutics plc (ITRM) Tuesday said that a meeting of the Food and Drug Administration's (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) to discuss the company's new drug application for oral Sulopenem for the treatment of uncomplicated urinary tract infections (uUTI) in adult women took place on September 9.
"We are encouraged by the AMDAC's discussion which acknowledged oral sulopenem as an important treatment option for certain patients with uUTI and agree that the appropriate use of oral sulopenem by treating physicians is critical to limiting antimicrobial resistance," said Corey Fishman, Iterum's Chief Executive Officer.
The AMDAC was provided scientific evidence including results from REASSURE, and SURE-1 Phase 3 studies.
The FDA is not bound by the recommendations of the AMDAC but takes its advice into consideration, the company said in a statement.
The Prescription Drug User Fee Act (PDUFA) goal date or the date on which a decision from the regulator is expected is October 25, 2024.
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