The U.S. Food and Drug Administration (FDA) has granted approval to Iterum Therapeutics' new drug application for ORLYNVAH™ (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women. This approval marks a significant advancement in combating antimicrobial resistance, providing a novel oral option for patients with limited alternative treatments. The decision is based on robust clinical data demonstrating ORLYNVAH™'s efficacy and safety against key uUTI-causing pathogens.
Clinical Trial Data
The FDA's approval was supported by data from two pivotal Phase 3 clinical trials, SURE 1 and REASSURE. The SURE 1 trial compared ORLYNVAH™ to ciprofloxacin, demonstrating superiority in treating fluoroquinolone-resistant infections. The REASSURE trial showed that ORLYNVAH™ was non-inferior and statistically superior to Augmentin™ in the Augmentin™-susceptible population. ORLYNVAH™ was generally well-tolerated in both trials.
Addressing Unmet Needs in uUTI Treatment
UTIs are among the most common bacterial infections, with up to 60% of women experiencing a uUTI in their lifetime. Approximately 40 million uUTI prescriptions are generated annually in the United States. Rising antibiotic resistance is making antibiotic selection more challenging for treating physicians. ORLYNVAH™ offers a potential solution to patients and physicians.
"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."
Mechanism of Action and Spectrum of Activity
ORLYNVAH™ is a novel oral penem antibiotic that 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. It is indicated for the treatment of uUTIs caused by designated microorganisms such as Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options.
Safety Information
ORLYNVAH™ is contraindicated in patients with a history of hypersensitivity to its components (sulopenem etzadroxil and probenecid) or other beta-lactam antibacterial drugs, patients with known blood dyscrasias, patients with known uric acid kidney stones, and concomitant use of ORLYNVAH™ and ketorolac tromethamine. Common adverse reactions include diarrhea, nausea, vulvovaginal mycotic infection, headache, and vomiting.
Future Plans for Iterum Therapeutics
Iterum Therapeutics is focused on maximizing the value of ORLYNVAH™ through strategic transactions, including potential partnerships, licensing agreements, or other collaborations. This approach aims to ensure that this new treatment option reaches patients in need and addresses the growing challenge of antimicrobial resistance.
"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," said Corey Fishman, Iterum's Chief Executive Officer. "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."
