Ironwood Phase III Data Emphasizes Likely Linzess Label Expansion
Executive Summary
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.
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With the acquisition of Swiss biotech firm VectivBio in late June, Ironwood Pharmaceuticals has firmly positioned itself as a gastrointestinal-focused company.
Ironwood Paying $1bn For VectivBio To Extend Its GI Franchise Beyond Linzess
Ironwood said it believes VectivBio’s once-weekly GLP-2 analog apraglutide is differentiated from Takeda’s once-daily Gattex in short bowel syndrome and could generate $1bn in peak sales.
Ironwood’s Phase III Data Could Expand Linzess Market Share
The company also hopes that positive safety data for pediatric patients could help with discussions with the FDA to make an OTC version of the drug.