Iterum's Orlynvah: FDA Approval, Clinical Trials, and Market Strategy for UTI Antibiotic

Iterum Therapeutics has achieved a pivotal milestone with the FDA approval of Orlynvah, marking it as the first oral penem antibiotic approved in the United States. This approval signifies Iterum's inaugural FDA-endorsed product and addresses the significant need for new treatments in uncomplicated urinary tract infections (uUTIs) in adult women[1][2]. The decision followed two key Phase III clinical trials, SURE 1 and REASSURE, highlighting Orlynvah's effectiveness against common antibiotics in resistant cases[2]. This approval comes after previous setbacks, with a resubmission that demonstrated the antibiotic's potential against specific bacterial strains like Escherichia coli and Klebsiella pneumoniae, underscoring its role in combating antibiotic resistance[1].