Iterum Therapeutics has announced that it received a Complete Response Letter (CRL) from the U.S. FDA for its New Drug Application for Sulopenem-etzadroxil/Probenecid, an antibiotic hopeful for the treatment of urinary tract infections.
With PDUFA action date on July 25, Iterum sought approval for Sulopenem in the treatment of uncomplicated urinary tract infections (uUTI) in patients with a quinolone non-susceptible organism. But the FDA wants more data, specifically recommending that Iterum conduct at least one additional adequate and well-controlled clinical trial, potentially using a different comparator drug.
On the bright side for small, Dublin-based biotech, the FDA acknowledged that Sulopenem showed clinical efficacy in terms of overall response rate compared with common antibiotic Ciprofloxacin in patients resistant to that drug. There were also no chemistry, manufacturing, or controls issues identified in the CRL, nor have there been any safety issues found in over 1,800 patients treated with Sulopenem across Iterum's clinical development program.
Iterum, which focuses on developing next-gen oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens, bought the drug from Pfizer in 2015. uUTIs are just one of several indications, including complicated urinary tract infections and complicated intra-abdominal infections, the company has explored for Sulopenem. Iterum has Qualified Infectious Disease Product and Fast Track designations for its oral and IV formulations of Sulopenem in seven indications — but so far has not brought the drug to market.
Iterum said it is planning to request a Type A meeting in the coming weeks, which it hopes will take place in Q3 2021. From there, Iterum intends to update the next steps of the marketing application before the resubmission of NDA.
Read the press release
