FDA approves first ever oral penem antibiotic in USA for uUTIs

The US Food and Drug Administration (FDA) approved Iterum Therapeutics’ (Nasdaq: ITRM) Orlynvah (sulopenem etzadroxil and probenecid) oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) caused by certain bacteria in adult women who have limited or no alternative oral antibacterial treatment options.

Chicago, USA-based Iterum suffered previous regulatory setbacks on the development of Orlynvah, and the news sent its shares soaring more than 60% to $1.88 by close of trading on Friday.

This is the first oral penem approved for use in the USA, and second FDA-approved treatment for uncomplicated urinary tract infections (uUTIs) in the past two decades, according to Iterum, which noted that this marks a huge advancement in fighting antibiotic resistance and in women’s health.