BOSTON — Ironwood Pharmaceuticals Inc. said the U.S. Food and Drug Administration has approved LINZESS for pediatric patients 2 years of age and older with functional constipation, expanding the treatment’s use to younger children.
The Boston-based biotechnology company said the approval makes LINZESS available to children ages 2 to 5 with functional constipation. The drug had previously been approved for pediatric patients 6 years of age and older with the condition.
Ironwood said LINZESS remains the only FDA-approved prescription therapy for pediatric functional constipation.
Functional constipation in children is a chronic condition marked by hard, infrequent bowel movements that are often difficult or painful to pass. The company said the condition is common among preschool children, with an estimated worldwide prevalence of 3%, though rates vary by 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,” said Julie Khlevner, M.D., a pediatric gastroenterologist at Columbia University Vagelos College of Physicians and Surgeons. “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.”
The FDA approval for children ages 2 to 5 was supported by data from a 12-week Phase 3 randomized, placebo-controlled clinical trial evaluating LINZESS in pediatric patients in that age group with functional constipation. Ironwood said LINZESS 72 mcg showed improvement in spontaneous bowel movement frequency compared with placebo.
The company said the safety profile observed in the trial was generally consistent with the established safety profile from studies in adults with chronic idiopathic constipation and older pediatric patients with functional constipation.
“This approval extends the use of LINZESS to younger patients with functional constipation, addressing an important gap in care for this historically underserved population, as reflected by the FDA’s decision to grant priority review,” said Tom McCourt, chief executive officer of Ironwood. “We see this as a natural progression for LINZESS that builds on a well-established safety and efficacy profile to expand the impact of our blockbuster medication in GI care.”
LINZESS has been prescribed to treat more than 5.5 million unique patients since its launch in 2012, according to Ironwood. The company said the drug is the prescription market leader for the treatment of irritable bowel syndrome with constipation in patients 7 years and older and chronic idiopathic constipation in adults.
LINZESS 72 mcg is available as a once-daily treatment for functional constipation in pediatric patients 2 years of age and older.
