Iterum Therapeutics faces a significant hurdle as an FDA advisory committee has recommended narrowing the indication for its antibiotic, sulopenem. The Antimicrobial Drugs Advisory Committee voted that the benefits of sulopenem outweigh the risks only when used in a limited population of patients with complicated urinary tract infections (cUTIs) who have limited or no alternative treatment options. This decision, made public recently, casts a shadow on the future of sulopenem as a broad-spectrum antibiotic.
The advisory committee's recommendation stems from concerns about the drug's potential to promote antimicrobial resistance, a growing threat in healthcare. While the committee acknowledged sulopenem's efficacy in treating cUTIs, its broad-spectrum activity raised alarms about unintended consequences on the microbiome and the potential for selecting resistant bacteria.
During the meeting, committee members emphasized the importance of stewardship and responsible antibiotic use. Several experts voiced concerns that a broad indication for sulopenem could lead to overuse, accelerating the development and spread of resistant organisms. This ultimately influenced the committee's decision to recommend a more restricted label.
Iterum Therapeutics now faces the challenge of working with the FDA to align the drug's label with the advisory committee's recommendations. This may involve conducting further studies to identify specific patient populations who would benefit most from sulopenem treatment while minimizing the risk of resistance. The company will need to present a compelling case to the FDA to ensure that sulopenem remains a viable option for patients with limited treatment alternatives. The FDA is not bound by the advisory committee's recommendation but typically takes it into consideration.
