Posted by Michael Wonder on 20 Mar 2019
Iterum Therapeutics receives QIDP for oral and IV sulopenem in four additional indications as well as fast track designation
19 March 2019 - New designations in community-acquired bacterial pneumonia, acute bacterial prostatitis, gonococcal urethritis, and pelvic inflammatory disease demonstrate the clinical potential of sulopenem.
Iterum Therapeutics today announced that the U.S. FDA has granted Qualified Infectious Disease Product (QIDP) to the oral and intravenous (IV) formulations of sulopenem in four new indications, community-acquired bacterial pneumonia, acute bacterial prostatitis, gonococcal urethritis, and pelvic inflammatory disease. These new designations augment Iterum’s existing QIDP designations for oral and IV sulopenem for the treatment of uncomplicated urinary tract infection (uUTI), complicated urinary tract infection (cUTI), and complicated intra-abdominal infection (cIAI), which the FDA granted in 2017.
The company is currently conducting three pivotal Phase 3 clinical trials in uUTI, cUTI and cIAI, and expects to report top-line results in the second half of 2019.
