Ironwood Pharmaceuticals, Inc., a gastrointestinalfocused healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has approved LINZESS® (linaclotide) as a method of treatment. once-daily treatment of dysfunctional pediatric patients 6 to 17 years of age. constipation. LINZESS is the first and only FDA-approved prescription treatment for functional constipation in this patient population. Earlier this year, the FDA authorized a 6-month priority review of our Supplemental New Drug Application (sNDA), which is 4 months earlier than the standard review schedule. LINZESS is developed and marketed by AbbVie and Ironwood Pharmaceuticals in the United States.
Functional constipation in children is a chronic condition characterized by hard, infrequent, often difficult or painful stools2. The disease affects about 6 million children ages 6 to 17 in the United States.
“When you have a child with functional constipation, it is extremely hard to watch them suffer – spending hours in the bathroom and away from their friends – while there is little you can do as a parent to help them,”
“There has long been a critical need for a new therapeutic option due to lack of approved prescription treatment options, so I’m thrilled that we now have a new prescription option for children that can effectively help address symptoms.”
Ceciel T. Rooker, President, International Foundation for Gastrointestinal Disorders.
FDA approval is based on the results of a large, multicenter, double-blind, phase III study evaluating LINZESS in patients 6 to 17 years of age with functional constipation. A total of 328 patients received study treatment, randomized to 1:1 ratio between LINZESS 72 mcg or placebo. In this pivotal study, linaclotide showed a clinically and statistically significant improvement over placebo in 12-week spontaneous bowel movement (SBM) rate (SBM/week), main will. Patients treated with linaclotide showed a two-fold greater mean change from baseline in SBM/week (2.6) than placebo (1.3) (p<0.0001). ). The most common adverse event in the Phase 3 pediatric study was diarrhea, which occurred in 4% of LINZESS-treated patients compared with 2% in the placebo group.
“Pediatric functional constipation is an all-too-common issue that physicians see every day, yet despite the tremendous distress it causes to our patients’ and their families, we haven’t had an FDA-approved prescription treatment to offer until now,”
“The approval of LINZESS for the treatment of functional constipation in pediatric patients ages 6-17 years-old is a meaningful advancement for these young patients.”
Jeffrey S. Hyams, M.D., Head, Division of Digestive Diseases, Hepatology, and Nutrition, Connecticut Children’s Medical Center, Professor of Pediatrics, University of Connecticut School of Medicine.
LINZESS was developed and marketed by Ironwood and AbbVie in the United States and has been available since 2012 to treat adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation ( CIC). Linaclotide, the active ingredient in LINZESS, is a first-class guanylate cyclase-C (GC-C) agonist and acts locally in the gut with minimal systemic exposure. Since its launch, it has been used to treat more than 4.5 million single adult patients with IBS-C and CIC.
“Today, Ironwood has broken new ground again in the history of LINZESS, extending the clinical utility of our blockbuster treatment to 6-17-year-olds seeking relief for functional constipation, a debilitating condition,”
“This approval is a momentous step forward in progressing our mission to advance the treatment of GI diseases and redefine the standard of care for GI patients and in ushering in a new era of growth for our company.”
Tom McCourt, chief executive officer of Ironwood.
Based on this FDA approval, LINZESS 72 mcg is now available for the treatment of functional constipation in pediatric patients 6-17 years of age, with immediate access to most patients based on an advanced form. advance on the coverage already available for the brand.
