1. Pink Sheet
  2. >>Regulatory Trackers
  3. >>US FDA Performance Tracker

Flawed But Approvable? Crafting Indication Possible Focus Of Iterum’s Antibiotic AdComm

 
• By Sarah Karlin-Smith

A second pivotal study may be enough to push Iterum’s antibiotic through its second FDA review, but data gaps raised concerns about inappropriate prescribing contributing to antimicrobial resistance and could limit marketing differentiation.

close up of person grasping pelvic area in pain
Antibiotic stewardship will be a key topic at Iterum's UTI treatment advisory committee meeting. • Source: Shutterstock

The US Food and Drug Administration may be willing to clear Iterum Therapeutics plc’s oral uncomplicated urinary tract infection (uUTI) treatment, if labeling can be written to guide physicians toward appropriate use and minimize the threat of antimicrobial resistance or cross-resistance to other carbapenems.

Key Takeaways

  • Iterum’s pivotal studies may be enough for a favorable benefit-risk balance, but not necessarily a label that offers key marketing advantages, such as use in patients who show signs of resistance to other uUTI treatments.

None of the flaws FDA outlined in the preview documents for sulopenem etzadroxil/probenecid's 9 September Antimicrobial Drugs Advisory Committee...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from US FDA Performance Tracker

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.

Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
• By Bridget Silverman

The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.

AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.

More from Regulatory Trackers

Global Pharma Guidance Tracker - April 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
• By Bridget Silverman

The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.