FDA grants priority review for linaclotide in pediatric patients

The US Food and Drug Administration (FDA) has granted Priority Review to the supplemental New Drug Application (sNDA) for linaclotide(LINZESS; Ironwood Pharmaceuticals) in pediatric patients aged 6 years and older with functional constipation (FC).

The current Prescription Drug User Fee Act date for linaclotide is June 14, 2023, which is 4 months before the standard review cycle. Priority review is given to treatments with the possibility of providing significant improvements to treatment, diagnosis, or prevention of severe conditions, or to supplements submitted to the Best Pharmaceuticals for Children Act.

FC is a chronic condition present in children, leading to hard, infrequent bowel movements which cause pain or are difficult to pass. About 6 million children aged 6 to 17 years in the United States are impacted by FC.

The sNDA filing followed a phase 3 study on linaclotide in pediatric patients aged 6 to 17 years with FC. There were 330 patients in the study, randomized into a linaclotide or placebo group. 

Spontaneous bowel movement (SBM) frequency rate after 12 weeks was measured as the primary endpoint of the study, with the linaclotide group seeing significant improvements in this endpoint compared to the placebo group. The average improvement seen in the linaclotide group was greater than 2-fold.

Stool consistency was measured as a secondary endpoint in the study, with the linaclotide group also seeing a significant improvement compared to placebo. Well-tolerance was also found in pediatric patients taking linaclotide. 

Diarrhea was the most common adverse event, presenting in 4.3% of patients taking linaclotide and 1.8% taking placebo. Other adverse events included abdominal pain, flatulence, headache, viral gastroenteritis, and abdominal distention.

Reference

Ironwood Pharmaceuticals announces FDA filing acceptance and priority review of supplemental new drug application for LINZESS® (linaclotide) for functional constipation in children and adolescents ages 6-17 years-old. Business Wire. February 13, 2023. Accessed February 13, 2023. https://www.businesswire.com/news/home/20230213005077/en/Ironwood-Pharmaceuticals-Announces-FDA-Filing-Acceptance-and-Priority-Review-of-Supplemental-New-Drug-Application-for-LINZESS%C2%AE-linaclotide-for-Functional-Constipation-in-Children-and-Adolescents-Ages-6-17-Years-Old