Iterum Therapeutics Receives FDA Acceptance of Resubmission of NDA for Oral Sulopenem for the treatment of Uncomplicated Urinary Tract Infections
Iterum Therapeutics announced that the FDA has accepted the resubmission of its New Drug Application (NDA) for oral sulopenem, aimed at treating uncomplicated urinary tract infections (uUTIs) in adult women. The FDA has assigned a PDUFA action date of October 25, 2024. This milestone follows the REASSURE clinical trial, which showed that oral sulopenem was non-inferior to Augmentin® and even demonstrated statistically significant superiority in overall success rate. The FDA's acceptance marks a critical step towards potentially providing a new treatment option for uUTIs, addressing a significant unmet medical need.
- FDA acceptance of NDA resubmission for oral sulopenem.
- PDUFA action date set for October 25, 2024.
- Oral sulopenem demonstrated statistically significant superiority over Augmentin® in clinical trials.
- Potential new treatment option for uncomplicated urinary tract infections in adult women.
- Successful key milestone in the regulatory approval process.
- Review period extends until October 25, 2024, delaying market entry.
- Dependence on positive FDA review and approval, which is not guaranteed.
Insights
Iterum Therapeutics' resubmission of their NDA for oral sulopenem has been accepted by the FDA, which is a pivotal milestone. The PDUFA action date is set for October 25, 2024. This is important because successful approval could significantly impact Iterum's revenue streams and overall market position. Investors should watch for further updates, particularly clinical trial data and FDA communications. The potential approval opens a new revenue channel in the uUTI treatment market, which is underserved and can benefit from new antibiotics targeting multi-drug resistant pathogens.
Financially, if approved, the commercial launch of oral sulopenem could drive a substantial increase in sales, leading to better financial performance for Iterum. However, there are uncertainties, such as potential competition and the pricing strategy Iterum will adopt, which could affect market penetration and profitability.
From a medical perspective, the resubmission and acceptance of the NDA for oral sulopenem are significant. The REASSURE clinical trial demonstrated that oral sulopenem is non-inferior to Augmentin® and showed statistically significant superiority in clinical and microbiologic response at the test-of-cure visit. This suggests that oral sulopenem could offer a robust new treatment option for uncomplicated urinary tract infections caused by resistant Enterobacterales.
For medical practitioners, the introduction of an effective oral antibiotic that can combat multi-drug resistant pathogens is a welcome development, as it provides a valuable tool in the ongoing battle against antibiotic resistance. This could lead to better patient outcomes and may reduce the healthcare burden associated with more complicated and resistant infections.
Oral Sulopenem NDA has been assigned a PDUFA action date of October 25, 2024
DUBLIN and CHICAGO, May 31, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the Company), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women. Under the Prescription Drug User Fee Act (“PDUFA”), the FDA has deemed the Company’s NDA resubmission to be a Class II complete response which has a six-month review period from the date of resubmission. As a result, the FDA has assigned a PDUFA action date of October 25, 2024.
“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."
The resubmission includes additional evidence from the REASSURE (REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales) clinical trial, conducted under Special Protocol Assessment agreement from the FDA, comparing oral sulopenem to oral Augmentin® in adult women with a uUTI, demonstrated that oral sulopenem was non-inferior to Augmentin® for the primary efficacy endpoint of clinical and microbiologic response at the test-of-cure visit for patients with an Augmentin® susceptible pathogen, with the difference in the overall success rate demonstrating statistically significant superiority of oral sulopenem versus Augmentin®.
About Iterum Therapeutics plc
Iterum Therapeutics plc is a clinical-stage pharmaceutical company dedicated to developing differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. The Company is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. The Company has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the Company’s plans, strategies and prospects for its business, including the development, therapeutic and market potential of sulopenem. In some cases, forward-looking statements can be identified by words such as “may,” “believes,” “intends,” “seeks,” “anticipates,” “plans,” “estimates,” “expects,” “should,” “assumes,” “continues,” “could,” “would,” “will,” “future,” “potential” or the negative of these or similar terms and phrases. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include all matters that are not historical facts. Actual future results may be materially different from what is expected due to factors largely outside the Company’s control, including the uncertainties inherent in the initiation and conduct of clinical and non-clinical development, changes in regulatory requirements or decisions of regulatory authorities, the timing of approval of any submission, changes in public policy or legislation, commercialization plans and timelines, if oral sulopenem is approved, the actions of third-party clinical research organizations, suppliers and manufacturers, the accuracy of the Company’s expectations regarding how far into the future the Company’s cash on hand will fund the Company’s ongoing operations, the sufficiency of the Company’s cash resources and the Company’s ability to continue as a going concern, the Company’s ability to maintain listing on the Nasdaq Capital Market, risks and uncertainties concerning the outcome, impact, effects and results of the Company’s pursuit of strategic alternatives, including the terms, timing, structure, value, benefits and costs of any strategic process and the Company’s ability to complete one, whether on attractive terms or at all, and other factors discussed under the caption “Risk Factors” in its most recently filed Annual Report on Form 10-K filed with the US Securities and Exchange Commission (SEC) on March 28, 2024, and other documents filed with the SEC from time to time. Forward-looking statements represent the Company’s beliefs and assumptions only as of the date of this press release. Except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
Investor Contact:
Judy Matthews
Chief Financial Officer 312-778-6073
IR@iterumtx.com
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