US FDA approves Ironwood Pharmaceuticals’ LINZESS
The FDA approval was based on the findings obtained from a double-blind multi-centre Phase III trial.
The US Food and Drug Administration (FDA) has granted approval for Ironwood Pharmaceuticals’ LINZESS (linaclotide) as a once-a-day treatment for functional constipation in paediatric patients aged between six and 17 years.
Developed and marketed by AbbVie and Ironwood in the US, LINZESS was previously approved to treat irritable bowel syndrome with constipation or chronic idiopathic constipation in adult patients.
It is the first and only prescription therapy to receive approval from the US FDA for functional constipation in paediatric patients.
Ironwood Pharmaceuticals CEO Tom McCourt stated: “Today, Ironwood has broken new ground again in the history of LINZESS, extending the clinical utility of our blockbuster treatment to six to 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.”
The regulatory approval was based on the findings obtained from a double-blind, multi-centre Phase III trial conducted in 328 functional constipation patients.
Treatment with linaclotide demonstrated a statistically significant and clinically meaningful improvement in the 12-week spontaneous bowel movement (SBM) frequency rate against placebo.
They also showed a more than two-fold least squares mean [LSM – a statistical method used to find or estimate the numerical values of parameters to fit a function to a set of data] change from baseline to 2.6 SBMs per week versus 1.3 SBMs per week with placebo.
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