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Iterum antibiotic gets FDA's qualified infectious disease, fast-track status


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Iterum antibiotic gets FDA's qualified infectious disease, fast-track status

Iterum Therapeutics plc's antibiotic, sulopenem, was granted the U.S. Food and Drug Administration's fast track designation and the qualified infectious disease product status.

The qualified infectious disease product, or QIDP, designation covers both the oral and intravenous formulations of sulopenem to treat community-acquired bacterial pneumonia, acute bacterial prostatitis, gonococcal urethritis and pelvic inflammatory disease.

Both formulations of the antibiotic had already received the QIDP status for treating uncomplicated urinary tract infection, complicated urinary tract infection and complicated intra-abdominal infection in 2017.

The Irish pharmaceutical company, which launched an IPO last year, is evaluating sulopenem for these three uses in three phase 3 trials, results from which are expected in the second half of the year.

The FDA's QIDP designation is given to those drug candidates that treat serious infections, particularly those caused by bacteria and fungi that are resistant to treatment or belong to treatment-resistant pathogens identified by the U.S. regulator. The status allows for certain incentives to develop the therapies.

In addition, all seven uses of sulopenem also secured the FDA's fast-track designation, which allows for eligibility for accelerated approval and priority review of an application.