– Expanded indication extends availability to children ages 2-5 with FC; previously approved in pediatric patients 6 years of age and older –

– LINZESS remains the first-and-only FDA-approved prescription therapy for pediatric FC –

Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD), a biotechnology company developing and commercializing life changing therapies for people living with gastrointestinal (GI) and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the use of LINZESS® (linaclotide) in pediatric patients 2 years of age and older with functional constipation (FC). LINZESS was previously approved for pediatric patients 6 years and older with FC. With this expanded indication, LINZESS is now available for children ages 2-5 years with FC and remains the only FDA-approved prescription therapy for pediatric FC.

Functional constipation in children is a chronic condition characterized by hard, infrequent bowel movements that are often difficult or painful to pass. It is common among preschool children, with an estimated worldwide prevalence of 3% that may vary by geographic region.