FDA Grants Priority Review for Linzess in Children, Adolescents


If approved, Linzess would be the first and only FDA-approved prescription therapy for functional constipation in children 6 to 17 years of age. The PDUFA date is June 14th, 2023.

The FDA has granted priority review to the supplemental new drug application (sNDA) for Linzess (linaclotide) to treat children and adolescents ages 6 to 17 years-old with functional constipation. The FDA has assigned the application a Prescription Drug User Fee Act (PDUFA) date of June 14th, 2023.

Developed by Ironwood Pharmaceuticals and AbbVie, Linzees Linaclotide is a guanylate cyclase-C (GC-C) agonist that is thought to work in two ways. It binds to the GC-C receptor locally, within the intestinal epithelium. Activation of GC-C results in increased intestinal fluid secretion and accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine.

Linzees is currently indicated for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation. Functional constipation affects an estimated 6 million children aged 6 to 17 years-old in the United States.

Michael Shetzline, M.D., Ph.D.

Michael Shetzline, M.D., Ph.D.

“Pediatric functional constipation has a significant impact on young patients and their families, yet there are no FDA-approved prescription therapies available for this population,” said Michael Shetzline, M.D., Ph.D., chief medical officer, senior vice president and head of research and drug development at Ironwood Pharmaceuticals.

The sNDA filing was based on the results of a phase 3 study that enrolled 330 patients who were randomized to either Linzess or placebo. Compared with placebo, Linzess showed a statistically significant and clinically meaningful improvement from baseline in 12-week spontaneous bowel movement frequency rate, meeting the primary endpoint. Linzess was well-tolerated in the pediatric population. The most common adverse event in the pediatric was diarrhea, which occurred in 4.3% of Linzess-treated patients versus 1.8% in the placebo group.

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