Iterum launches ORLYNVAH, first oral penem antibiotic in U.S., for uUTI

Iterum Therapeutics plc

FDA approved ORLYNVAH in Oct 2024; commercial launch announced Aug 20, 2025.
First oral penem antibiotic in U.S.; first new branded uUTI product in >25 years.
57% of initial uUTIs resistant to at least one antibiotic class per 2024 study.
Copay savings program allows eligible patients to get ORLYNVAH for as low as $25.
CEO cites urgent need for new oral therapies amid rising antibiotic resistance.

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