Abhoy Sarkar's Avatar
published in Blogs
Jul 27, 2021
Iterum (ITRM, $0.63) denied approval by FDA for UTI Treatment

Iterum (ITRM, $0.63) denied approval by FDA for UTI Treatment

Iterum Therapeutics plc  said that it will not get approval for the current form of its new drug application for oral sulopenem.

According to the Food and Drug Administration (FDA), additional data are required and the company should conduct at least one more well-controlled clinical trial for its treatment of adult women with uncomplicated urinary tract infections. FDA mentioned that it is willing to work with Iterum on the design of clinical trials in order to address the issues the FDA identified.

However, Iterum CEO Corey Fishman  said the company is “disappointed in this outcome and believe that the data package submitted was adequate for the approval of oral sulopenem,” . Fishman added that they will still assess the points raised in the CRL for discussion with the FDA to determine an “expeditious path forward."

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