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Ironwood Phase III Data Emphasizes Likely Linzess Label Expansion

 
• By David Wild

Ironwood presented Phase III data on Linzess (linaclotide) at Digestive Disease Week for the treatment of 6-17 year-olds with functional constipation; US FDA approval is expected in a month.

Positive data presented at Digestive Disease Week underscore the likelihood that Ironwood Pharmaceuticals will successfully expand their Linzess (linaclotide) label to include patients aged 6-17 years of age with functional constipation (FC). The US Food and Drug Administration decision, which has a 14 June user fee date, would be welcome news for a company that in 2020 was cutting jobs because revenue was not flowing as hoped for. 

Functional constipation is the most common gut-brain disorder in children in the US, leaving 6 million people 6-17 years of age with degraded quality of life and no FDA-approved treatments.

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