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Ironwood Says US FDA Approves Linzess Use in Children Aged Two Years and Older With Functional Constipation

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Ironwood Pharmaceuticals (IRWD) has secured US Food and Drug Administration approval for expanded use of Linzess or linaclotide to treat younger pediatric patients with functional constipation, the company said Wednesday.

The expanded label extends availability of the drug for children between the age of 2 and 5, Ironwood said. Linzess was previously approved for pediatric patients aged 6 and above, it added.

The approval for pediatric patients ages 2-5 was supported by data from a 12-week phase 3 trial, which showed improvement in spontaneous bowel movement frequency compared with placebo, the company said.

Shares of the company were 1.7% higher in Wednesday trading.

Price: $3.96, Change: $+0.06, Percent Change: +1.41%

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