The FDA approval is based on the findings from a Phase 3 trial which showed a statistically significant and clinically meaningful improvement against the placebo in spontaneous bowel movement
LINZESS is now approved as a once-daily treatment to treat functional constipation. (Credit: Darko Djurin from Pixabay)
Ironwood Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved its Linzess (linaclotide) as a once-daily treatment to treat paediatric patients aged six to 17 years with functional constipation.
Linzess, developed and marketed by AbbVie and Ironwood in the US, is designed to treat both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in adults and functional constipation (FC) in children and youth six to 17 years of age.
The once-daily treatment is now said to be the first and only FDA-approved prescription therapy for FC in paediatric patients.
The FDA approval is based on the findings from a multicentre, double-blind, Phase 3 study.
The trial assessed Linzess in 328 patients aged six to 17 years with FC and the patients were randomised in a 1:1 ratio between Linzess 72 mcg or placebo.
Its primary endpoint was a 12-week change from baseline in spontaneous bowel movement (SBM) frequency rate (SBMs/week).
As per the results, the functional constipation drug showed a statistically significant and clinically meaningful improvement against the placebo in SBMs/week.
The patients treated with Linzess also showed more than two-fold least squares mean change from baseline in SBMs/week (2.6) compared to placebo (1.3).
Ironwood CEO Tom McCourt said: “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.”
In February this year, the US health regulator granted priority review to the supplemental New Drug Application (sNDA) for Linzess to treat FC. The FDA gave the application a Prescription Drug User Fee Act (PDUFA) date of 14 June 2023, which was reportedly four months earlier than the standard review cycle.