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Ironwood To Consider All Options With Apraglutide Setback In SBS

 
• By Joseph Haas

With the FDA asking for another Phase III trial, the short bowel syndrome drug apraglutide could be years away from market, while the Linzess patent expiry and near-term debt loom.

Ironwood is farther away now from its goal of getting apraglutide approved (Shutterstock)

Ironwood Pharmaceuticals’ future looks uncertain after it revealed on 14 April that the US Food and Drug Administration indicated that it will need to see a confirmatory Phase III trial on top of data the firm already has produced for its GLP-2 analog apraglutide in short bowel syndrome. The Boston biotech said it will work with the agency to design a new Phase III trial but is also considering its strategic alternatives.

Key Takeaways
  • An FDA request for a confirmatory Phase III trial for its lead candidate apraglutide, puts Ironwood is in financial straits, with declining revenue for its...

The regulatory setback comes after Ironwood initiated a rolling submission to the FDA in January for apraglutide in SBS with intestinal failure (SBS-IF), an indication that would put it in...

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