FDA Approves Expanded Linzess Use for Pediatric Functional Constipation in Children Aged 2 and Older – Ironwood Pharmaceuticals

Ironwood Pharmaceuticals  announced that the 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.

“Managing functional constipation in young children is especially challenging, as this vulnerable patient population often continues to experience persistent symptoms despite treatment with over-the-counter therapies. Clinicians must carefully balance safety, efficacy and the practical realities of what treatments young children are able and willing to take consistently. The availability of an FDA-approved therapy with an established safety profile expands evidence-based treatment options and may support a more tailored therapeutic approach for children aged 2-5 years. Parents can mix the contents of the Linzess capsule with applesauce or water, providing flexibility for administration in young children.” – Julie Khlevner, M.D., a pediatric gastroenterologist at Columbia University Vagelos College of Physicians and Surgeons.

The FDA approval for pediatric patients ages 2-5 was supported by data from a 12-week Phase 3 randomized, placebo-controlled clinical trial evaluating Linzess in pediatric patients aged 2-5 years with FC. In the study, Linzess 72 mcg demonstrated improvement in spontaneous bowel movement frequency compared with placebo. The safety profile of Linzess observed in the trial was generally consistent with the established safety profile from trials in adults with chronic idiopathic constipation (CIC) and older pediatric patients with FC.

Since its launch in 2012, Linzess has been prescribed to treat more than 5.5 million unique patients and is the prescription market leader for the treatment of IBS-C (7 years and older) and adults with CIC.

Linzess 72mcg is available as a once-daily treatment of FC for pediatric patients 2 years of age and older with accessibility for most patients building on established class-leading formulary coverage already in place for the brand.