Ironwood Pharmaceuticals Inc. (IRWD), a biotechnology company, on Wednesday announced approval from the U.S Food and Drug Administration (FDA) for the use of LINZESS in patients aged 2 years and older in treating functional constipation.
Functional constipation (FC) is characterized by hard, infrequent bowel movements that are often difficult or painful to pass. The chronic condition is common among preschool-aged children, with a worldwide prevalence of 3% or more.
LINZESS is a GC-C receptor agonist that received FDA approval in 2012 for treating irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in adults. Co-developed and co-commercialized with AbbVie in the U.S., it has since been prescribed for over 5.5 million patients and was approved for use in pediatric patients aged 6 years and older.
The approval was supported by data from a 12-week Phase 3 randomized, placebo-controlled trial evaluating LINZESS in pediatric patients of FC between 2-5 years of age. The drug demonstrated improvement in spontaneous bowel movement and showed a favorable safety profile.
LINZESS is now available as a 72 mcg dose for pediatric patients of FC.
IRWD closed Wednesday at $3.71, down 4.87%. In the overnight market, shares are trading at $3.69, down 0.54%.
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