US FDA hits the brakes on novel urinary tract infection treatment

27 July 2021

Chicago, USA-based antimicrobial resistance specialist Iterum Therapeutics (Nasdaq: ITRM) announced a regulatory setback for its candidate, oral sulopenem, on Monday.

Having completed its review of the data, the US Food and Drug Administration issued the firm a Complete Response Letter (CRL), stating that additional data are necessary to support approval.

Iterum is looking to offer the treatment, a combination of sulopenem etzadroxil and probenecid, for certain women with uncomplicated urinary tract infections.

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