Ironwood Pharmaceuticals Announces FDA Approval Of Revised LINZESS® Linaclotide Label
Ironwood Pharmaceuticals, Inc., a GI-focused healthcare company, today announced that the U.S. Food and Drug Administration (FDA) approved a revised label for LINZESS® (linaclotide) based on clinical safety data that has been generated thus far in pediatric studies. The updated label modifies the boxed warning for risk of serious dehydration and contraindication against use in children to those less than two years of age. The boxed warning and contraindication previously applied to all children less than 18 years of age and less than 6 years of age, respectively. The safety and effectiveness of LINZESS in patients less than 18 years of age have not been established. LINZESS is indicated in adults for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).
“The warning on the LINZESS label at launch was primarily applied due to preclinical findings, and there was an absence of any clinical data in pediatric populations at the time,” said Michael Shetzline, M.D., Ph. D, chief medical officer, senior vice president and head of drug development at Ironwood. “Since approval, we have worked diligently on generating clinical data to better characterize the safety profile for pediatric populations. This label update reflects a significant milestone, and we look forward to continuing to investigate the safety and efficacy of LINZESS for children.”
The LINZESS prescribing information continues to include a boxed warning for children less than 2 years of age and a contraindication against use in this population. Further clinical data are also required to establish the safety and efficacy of LINZESS in the pediatric population (less than 18 years of age). Diarrhea, including severe diarrhea, is a potentially serious side effect of LINZESS.
The approved revision to the boxed warning and the safety information of LINZESS in children is based on pediatric clinical safety data, including:
- Clinical studies that enrolled patients with functional constipation (FC) and those with irritable bowel syndrome with constipation (IBS-C); as well as clinical study data in children with FC
- Data from a human guanylate-cyclase (GC-C) expression study in pediatric subjects. LINZESS is a GC-C agonist
- Post-marketing data from the LINZESS global safety database in children who took LINZESS
- An analysis of the IBM® MarketScan® Database assessing the use of LINZESS in pediatric patients from the United States and
- Safety and efficacy results from a retrospective review of children at the Nationwide Children’s Hospital in Columbus, Ohio1 with FC or IBS-C who had taken LINZESS.