Iterum Therapeutics' Orlynvah Receives FDA Approval for Uncomplicated Urinary Tract Infections
Key Insights
Iterum Therapeutics (search) secures FDA approval for Orlynvah (sulopenem etzadroxil and probenecid) to treat uncomplicated urinary tract infections (search) (uUTIs) in adult women.
Orlynvah is indicated for uUTIs caused by Escherichia coli (search), Klebsiella pneumoniae (search), or Proteus mirabilis (search), offering a new oral antibacterial option.
As the first oral penem approved in the U.S., Orlynvah addresses antimicrobial resistance and provides an alternative for patients with limited treatment options.
Iterum Therapeutics (search) has achieved a significant milestone with the FDA's approval of Orlynvah (sulopenem etzadroxil and probenecid) for treating uncomplicated urinary tract infections (search) (uUTIs) in adult women. This approval marks the first for Orlynvah and represents Iterum's first FDA-approved product.
Addressing Unmet Needs in UTI Treatment
Orlynvah is specifically indicated for uUTIs caused by designated microorganisms, including Escherichia coli (search), Klebsiella pneumoniae (search), and Proteus mirabilis (search), in adult women who have limited or no alternative oral antibacterial treatment options. The approval offers new hope for patients facing difficult-to-treat UTIs and combats antimicrobial resistance to other approved oral agents.
"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, site chief, infectious disease at 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."
A Novel Oral Penem
As the first oral penem approved in the U.S., Orlynvah provides an alternative treatment option for appropriate patients in the underserved uUTI market. The drug's approval comes with a clear label, and Iterum Therapeutics (search) is now focusing on securing a strategic transaction involving Orlynvah to maximize value for its stakeholders.
"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," said Corey Fishman, Iterum’s CEO. "Orlynvah offers new hope for patients suffering from difficult-to-treat UTIs. 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."