The clock is ticking for Iterum after FDA hands down CRL for Pfizer castoff antibiotic
Iterum knew its odds were slim as it awaited an FDA ruling on a key urinary tract infection drug with its bank account running low. The FDA, however, wasn’t impressed, and Iterum’s days look numbered.
The FDA has sent the tiny biotech a complete response letter for the antibiotic sulopenem, shutting down hopes at getting the oral medication across the finish line, the drugmaker revealed Monday.
In Iterum’s telling of the details — the letter was not made public — the FDA pushed back on the drug’s application in women with uncomplicated UTIs caused by “designated susceptible microorganisms proven or strongly suspected to be non-susceptible to a quinolone” due to a lack of clinical data.
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