Will fda approve itrm

The FDA's decision on whether to approve Iterum Therapeutics' (ITRM) sulopenem etzadroxil/probenecid for the treatment of uncomplicated urinary tract infections (uUTI) in adult women is expected by the Prescription Drug User Fee Act (PDUFA) goal date of October 25, 2024

1. FDA Review Process: The FDA's review process for the drug application includes the consideration of both the benefits and risks associated with the drug. The FDA has already convened an Antimicrobial Drugs Advisory Committee (AMDAC) meeting to discuss the application and gather information on the drug's benefits and risks.
2. AMDAC Discussion: The AMDAC acknowledged oral sulopenem as an important treatment option for certain patients with uUTI and agreed that appropriate use by treating physicians is critical to limiting antimicrobial resistance. However, the panel also discussed limitations or instructions that would need to be included in the product's labeling to prevent inappropriate use and limit antimicrobial resistance.
3. Previous Rejections and Resubmissions: Iterum had previously submitted an application for sulopenem, which was rejected by the FDA in 2021 due to the need for additional clinical trials. The company resubmitted the application in April 2024 with data from the pivotal REASSURE and SURE-1 Phase 3 clinical trials.
4. Clinical Trial Data: The FDA was provided with scientific evidence from Iterum, including data from the REASSURE and SURE-1 Phase 3 clinical trials. These trials showed that sulopenem etzadroxil/probenecid was superior to ciprofloxacin for the overall response rate in the microbiological modified intent to treat-resistant population with ciprofloxacin-resistant pathogens.
5. Market Need: The FDA recognizes the need for new antibiotics to treat uUTIs, especially in light of increasing antimicrobial resistance. Sulopenem etzadroxil/probenecid has the potential to be the first oral penem approved in the U.S..
6. Financial Implications: The potential approval of sulopenem etzadroxil/probenecid could have a significant financial impact on Iterum Therapeutics, as it would be the first oral penem approved in the U.S..

In conclusion, while there is encouragement from the AMDAC discussion, the final decision rests with the FDA. Given the market need and the positive outcomes from the clinical trials, there is a reasonable expectation that the FDA will approve sulopenem etzadroxil/probenecid for the indicated uUTI treatment by the PDUFA goal date.