QIDP Program Heads Into Uncomplicated Territory: Iterum, Paratek Eye uUTI Indications
Iterum’ssulopenem is first QIDP candidate to enter Phase III for uncomplicated urinary tract infection; Paratek’sNuzyra could be next.
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Iterum’s antibiotic sulopenem missed its endpoint by the equivalent of one patient. The company believes the Phase III data could still support its NDA for urinary tract infections.
US FDA's Qualified Infectious Disease Product program is growing slowly, but still growing.
Company still mulling pricing for broad-spectrum antibiotic Nuzyra (omadacycline), which is set to launch in the US in the first quarter, following FDA approval Oct. 2.