FDA Approves Orlynvah for Treatment of Uncomplicated UTIs in Women with Limited Options

Key Insights

• The FDA has approved Orlynvah (sulopenem etzadroxil and probenecid), an oral antibiotic, for uncomplicated urinary tract infections (UTIs) in adult women with limited treatment options.
• Orlynvah is intended for use when other oral antibacterial treatments are not suitable or unavailable, addressing a critical unmet need for women facing recurrent UTIs.
• Clinical trials demonstrated the drug's efficacy in treating UTIs caused by susceptible bacteria, offering a new option for patients who have run out of alternatives.

The U.S. Food and Drug Administration (FDA) has granted approval to Iterum Therapeutics' Orlynvah (sulopenem etzadroxil and probenecid), an oral antibiotic, for the treatment of uncomplicated urinary tract infections (UTIs) in adult women. This approval addresses a significant gap in treatment options for women who have limited or no alternative oral antibacterial therapies available.

Addressing Unmet Needs in UTI Treatment

UTIs are common bacterial infections, particularly among women. Orlynvah is specifically indicated for uncomplicated UTIs caused by susceptible bacteria in women who have exhausted other oral treatment options. This approval provides a new tool for healthcare providers facing the challenge of recurrent or resistant UTIs.

The drug is expected to be available around mid-2025.

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