Iterum Therapeutics Receives U.S. FDA Approval of ORLYNVAH™ (Oral Sulopenem) for the Treatment of Uncomplicated Urinary Tract Infections
Iterum Therapeutics (Nasdaq: ITRM) has received FDA approval for ORLYNVAH™, the first oral penem approved in the U.S. for treating uncomplicated urinary tract infections (uUTIs). The drug is specifically approved for adult women with or no alternative oral antibacterial treatment options against designated microorganisms. The approval is based on two Phase 3 clinical trials, SURE 1 and REASSURE, which demonstrated superiority to ciprofloxacin in fluoroquinolone resistant infections and statistical superiority to Augmentin™ in the susceptible population, respectively. ORLYNVAH™ represents the second FDA-approved treatment for uUTIs in the past two decades.
Iterum Therapeutics (Nasdaq: ITRM) ha ricevuto l'approvazione della FDA per ORLYNVAH™, il primo penem orale approvato negli Stati Uniti per il trattamento delle infezioni urinarie non complicate (uUTI). Il farmaco è specificamente approvato per donne adulte con poche o nessuna opzione di trattamento antibiotico orale alternativa contro microorganismi designati. L'approvazione si basa su due studi clinici di Fase 3, SURE 1 e REASSURE, che hanno dimostrato una superiorità rispetto alla ciprofloxacina nelle infezioni resistenti ai fluoroquinoloni e una superiorità statistica rispetto ad Augmentin™ nella popolazione suscettibile, rispettivamente. ORLYNVAH™ rappresenta il secondo trattamento approvato dalla FDA per le uUTI negli ultimi vent'anni.
Iterum Therapeutics (Nasdaq: ITRM) ha recibido la aprobación de la FDA para ORLYNVAH™, el primer penem oral aprobado en los EE. UU. para tratar infecciones urinarias no complicadas (uUTI). El medicamento está específicamente aprobado para mujeres adultas con pocas o sin opciones alternativas de tratamiento antibacteriano oral contra microorganismos designados. La aprobación se basa en dos ensayos clínicos de Fase 3, SURE 1 y REASSURE, que demostraron ser superiores a la ciprofloxacina en infecciones resistentes a fluoroquinolonas y una superioridad estadística frente a Augmentin™ en la población susceptible, respectivamente. ORLYNVAH™ representa el segundo tratamiento aprobado por la FDA para uUTI en las últimas dos décadas.
Iterum Therapeutics (Nasdaq: ITRM)는 ORLYNVAH™에 대한 FDA의 승인을 받았습니다. 이는 미국에서 비복잡성 요로 감염(uUTI)을 치료하기 위해 승인된 첫 번째 경구 펜엠입니다. 이 약물은 지정된 미생물에 대한 대체 경구 항균 치료 옵션이 거의 없거나 전혀 없는 성인 여성에게 특별히 승인되었습니다. 이 승인은 ciprofloxacin에 대한 우수성을 입증한 두 개의 3상 임상시험인 SURE 1과 REASSURE를 기반으로 하며, 각각의 감수성 집단에서 Augmentin™에 대한 통계적 우수성을 보여주었습니다. ORLYNVAH™는 지난 20년 동안 uUTI에 대해 FDA의 승인을 받은 두 번째 치료제입니다.
Iterum Therapeutics (Nasdaq: ITRM) a reçu l'approbation de la FDA pour ORLYNVAH™, le premier pénem oral approuvé aux États-Unis pour le traitement des infections urinaires non compliquées (uUTI). Le médicament est spécifiquement approuvé pour les femmes adultes avec peu ou aucune option de traitement antibactérien oral alternatif contre les microorganismes désignés. L'approbation est basée sur deux essais cliniques de phase 3, SURE 1 et REASSURE, qui ont démontré une supériorité par rapport à la ciprofloxacine dans les infections résistantes aux fluoroquinolones et une supériorité statistique par rapport à Augmentin™ dans la population sensible, respectivement. ORLYNVAH™ représente le deuxième traitement approuvé par la FDA pour les uUTI au cours des vingt dernières années.
Iterum Therapeutics (Nasdaq: ITRM) hat die FDA-Zulassung für ORLYNVAH™ erhalten, das erste orale Penem, das in den USA zur Behandlung von unkomplizierten Harnwegsinfektionen (uUTI) zugelassen ist. Das Arzneimittel ist speziell für erwachsene Frauen ohne oder mit nur wenigen alternativen oralen antibakteriellen Behandlungsmöglichkeiten gegen vorgesehene Mikroorganismen zugelassen. Die Zulassung basiert auf zwei klinischen Studien der Phase 3, SURE 1 und REASSURE, die eine Überlegenheit gegenüber Ciprofloxacin bei fluoroquinolon-resistenten Infektionen und eine statistische Überlegenheit gegenüber Augmentin™ in der empfänglichen Population nachwiesen. ORLYNVAH™ stellt die zweite von der FDA zugelassene Behandlung für uUTI in den letzten zwei Jahrzehnten dar.
- First oral penem approved in the U.S. market
- Demonstrated superiority over existing treatments in clinical trials
- Addresses an underserved market with treatment options
- First FDA-approved product for Iterum Therapeutics
- Company pursuing strategic transaction to maximize stakeholder value
- approval scope (only for adult women with /no alternatives)
- Market restricted to specific microorganisms only
Insights
The FDA approval of ORLYNVAH™ represents a significant breakthrough in the treatment of uncomplicated urinary tract infections (uUTIs). This is particularly noteworthy as it's only the second FDA-approved treatment for uUTIs in two decades and the first oral penem approved in the U.S.
The clinical data is robust, with two pivotal Phase 3 trials demonstrating:
- Superiority over ciprofloxacin in fluoroquinolone resistant infections (SURE 1 trial)
- Non-inferiority and statistical superiority to Augmentin™ in susceptible populations (REASSURE trial)
For a micro-cap company (
This approval positions Iterum strategically in the lucrative UTI market. With antimicrobial resistance becoming a global health crisis, ORLYNVAH™'s unique position as the first oral penem in the U.S. creates substantial market opportunity. The company's clear intention to pursue strategic transactions suggests potential partnership or acquisition deals ahead, which could significantly impact shareholder value.
The well-defined label and demonstrated superiority over existing treatments in specific populations provide strong commercial positioning. The timing is particularly advantageous given the innovation in this space over the past 20 years, potentially allowing for premium pricing and rapid market penetration.
ORLYNVAH™ is the first oral penem approved for use in the U.S. and the second FDA-approved treatment for uUTIs in the past two decades
--Company to Host Conference Call on Monday, October 28th at 8:30 a.m. EDT--
DUBLIN and CHICAGO, Oct. 25, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), today announced that the U.S. Food and Drug Administration (FDA) has approved Iterum’s new drug application for ORLYNVAH™ (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (uUTIs) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. This is the first approved indication for ORLYNVAH™ and the first FDA-approved product for Iterum.
“We are so pleased to have achieved this historic milestone and would like to thank all the patients, investigators, Iterum colleagues and Iterum consultants and vendors who participated in the development of ORLYNVAH™. ORLYNVAH™ offers new hope for patients suffering from difficult-to-treat uUTIs. The introduction of novel products, like ORLYNVAH™, is an important way to combat antimicrobial resistance to other approved oral agents and offers a potential solution to patients and physicians,” said Corey Fishman, Iterum’s Chief Executive Officer. “As the first oral penem approved in the U.S., ORLYNVAH™ offers an excellent alternative treatment option for appropriate patients in the underserved uUTI market. With FDA approval and a clear label, we will renew our efforts to achieve a strategic transaction involving ORLYNVAH™ with the goal of maximizing value for our stakeholders.”
The FDA approval of ORLYNVAH™ was based on a clinical development program supported by a robust data package, including two pivotal, Phase 3 clinical trials (known as SURE 1 and REASSURE) that evaluated the safety and efficacy of ORLYNVAH™ compared to ciprofloxacin (SURE 1) and Augmentin™ (REASSURE) in the treatment of adult women with uUTI. SURE 1 showed superiority to ciprofloxacin in fluoroquinolone resistant infections, while REASSURE showed non-inferiority and statistical superiority to Augmentin™ in the Augmentin™ susceptible population. ORLYNVAH™ was generally well tolerated in both SURE 1 and REASSURE clinical trials.
“The FDA approval of ORLYNVAH™ is tremendous news for those of us who have been hoping for a new option to treat appropriate at-risk patients suffering from UTIs,” said Marjorie Golden, MD, FIDSA, Site Chief, Infectious Disease, St. Raphael Campus Yale New Haven Hospital. “Based on the totality of clinical data generated, ORLYNVAH™ has the potential to be an important treatment alternative for use in the community.”
Conference Call
Iterum will host a conference call on Monday, October 28, 2024, at 8:30 a.m. Eastern Time. The dial-in information for the call is as follows:
United States: 1 833 470 1428 / International: 1 404 975 4839
Access code: 936149
The conference call replay will be available in the Events & Presentations section of Iterum’s website following the call.
About uUTIs
UTIs are among the most common bacterial infections encountered in the community. uUTIs are infections of the bladder occurring mainly in women. Up to
About ORLYNVAH™
ORLYNVAH™ is a novel oral penem antibiotic for the treatment of uUTI. ORLYNVAH™ possesses potent activity against species of Enterobacterales including those that encode extended spectrum beta-lactamase (ESBL) or AmpC-type beta-lactamases that confer resistance to third generation cephalosporins.
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATIONS & USAGE
ORLYNVAH™ a combination of sulopenem etzadroxil, a penem antibacterial, and probenecid, a renal tubular transport inhibitor, is indicated for the treatment of uUTI caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options.
Limitations of Use
ORLYNVAH™ is not indicated for the treatment of:
- Complicated urinary tract infections (cUTI) or as step-down treatment after intravenous antibacterial treatment of cUTI.
- Complicated intra-abdominal infections (cIAI) or as step-down treatment after intravenous antibacterial treatment of cIAI.
Usage to Reduce Development of Drug-Resistant Bacteria
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ORLYNVAH™ and other antibacterial drugs, ORLYNVAH™ should be used only to treat uUTI that are proven or strongly suspected to be caused by susceptible bacteria. Culture and susceptibility information should be utilized in selecting or modifying antibacterial therapy.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
- Patients with a history of hypersensitivity to the components of ORLYNVAH™ (sulopenem etzadroxil and probenecid) or other beta-lactam antibacterial drugs.
- Patients with known blood dyscrasias.
- Patients with known uric acid kidney stones.
- Concomitant use of ORLYNVAH™ and ketorolac tromethamine is contraindicated.
WARNINGS AND PRECAUTIONS
- Hypersensitivity Reactions: Hypersensitivity reactions have been reported in patients treated with ORLYNVAH™. Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis, have been reported with beta-lactam antibacterial drugs. Severe allergic reactions and anaphylaxis have been reported with the use of probenecid (a component of ORLYNVAH™). If an allergic reaction to ORLYNVAH™ occurs, discontinue the drug and institute appropriate therapy.
- Clostridioides difficile-Associated Diarrhea (CDAD): This has been reported with nearly all systemic antibacterial agents. Evaluate if diarrhea occurs.
- Exacerbation of Gout: When prescribing ORLYNVAH™ to patients with a known history of gout, ensure appropriate therapy of gout is instituted.
ADVERSE REACTIONS
The most common adverse reactions (≥
DRUG INTERACTIONS
- Ketoprofen: Concomitant use is not recommended.
- See full prescribing information for additional clinically significant drug interactions with ORLYNVAH™.
USE IN SPECIFIC POPULATIONS
- There are no available data on ORLYNVAH™ use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
- There are no data on the presence of ORLYNVAH™ or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production.
- The safety and effectiveness of ORLYNVAH™ in pediatric patients have not been established.
- No dosage adjustment based on age is required. ORLYNVAH™ is known to be substantially excreted by the kidney, and geriatric patients are anticipated to have reduced renal function. Recommendations for use in elderly patients should be based on renal function.
- Increases in sulopenem plasma concentrations were observed with mild, moderate and severe renal impairment; however, the available safety information does not suggest a need for dosage adjustments in these patients. Administration of ORLYNVAH™ is not recommended in patients with creatinine clearance (CrCL) less than 15 mL/min and patients on hemodialysis because the pharmacokinetics of sulopenem have not been studied in this population.
To report SUSPECTED ADVERSE REACTIONS, contact Iterum Therapeutics plc at 1-866-414-SULO or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
About Iterum Therapeutics plc
Iterum Therapeutics plc is focused on delivering 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. Iterum is advancing the development of its first compound, sulopenem, a novel penem anti-infective compound, 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. Iterum has received approval of its NDA for ORLYNVAH™ (oral sulopenem) for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women with limited or no alternative oral antibacterial treatment options by the U.S. Food and Drug Administration and has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications. For more information, please visit www.iterumtx.com.
Cautionary Note Regarding 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 Iterum’s plans, strategies and prospects for its business, including the development, therapeutic and market potential of ORLYNVAH™ and Iterum’s strategic process to sell, license, or otherwise dispose of its rights to ORLYNVAH™. 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 Iterum’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 Iterum’s control, including risks and uncertainties concerning the outcome, impact, effects and results of Iterum’s evaluation of strategic alternatives, including the terms, timing, structure, value, benefits and costs of any strategic alternatives, Iterum’s ability to complete a strategic alternative transaction, the market opportunity for and the potential market acceptance of ORLYNVAH™ for uUTIs caused by certain designated microorganisms in adult women who have limited or no alternative oral antibacterial treatment options, uncertainties inherent in the conduct of clinical and non-clinical development, changes in regulatory requirements or decisions of regulatory authorities, the timing or likelihood of regulatory filings and approvals, changes in public policy or legislation, commercialization plans and timelines, the actions of third-party clinical research organizations, suppliers and manufacturers, the accuracy of Iterum’s expectations regarding how far into the future Iterum’s cash on hand will fund Iterum’s ongoing operations, Iterum’s ability to maintain its listing on the Nasdaq Capital Market and other factors discussed under the caption “Risk Factors” in its Quarterly Report on Form 10-Q filed with the SEC on August 14, 2024, and other documents filed with the SEC from time to time. Forward-looking statements represent Iterum’s beliefs and assumptions only as of the date of this press release. Except as required by law, Iterum 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
FAQ
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