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AbbVie submits sNDA for linaclotide for functional constipation in children and adolescents

If approved, according to AbbVie, linaclotide would be the first prescription therapy for FC in this patient population.

AbbVie has announced the submission of a supplemental New Drug Application to the US Food and Drug Administration for linaclotide (LINZESS; AbbVie) for the potential treatment of functional constipation (FC) in children and adolescents 6 to 17 years. If approved, according to AbbVie, linaclotide would be the first prescription therapy for FC in this patient population.

This submission is based on positive results from a recent phase 3 clinical trial evaluating linaclotide (72 mcg) in patients 6 to 17 years with FC, where the drug met the study’s primary and secondary endpoints.

"Although functional constipation is common among pediatric patients, it has long been difficult to manage due to a lack of approved prescription treatment options," said Celine Goldberger, MD, PhD, vice president, head of US medical affairs, AbbVie. "This milestone demonstrates our tireless work to advance the standards of care in order to make a difference in patients' lives."

In the phase 3, multicenter, double-blind study, 330 patients were enrolled and randomized in a 1:1 ratio to receive either linaclotide or placebo.

In the study, linaclotide demonstrated a statistically significant and clinically meaningful improvement vs placebo in the primary endpoint, 12-week spontaneous bowel movement (SBM) frequency rate (SBMs/week). Also, patients who received linaclotide showed a greater than 2-fold least squares mean change from baseline in SBMs/week (2.220) vs to placebo (1.050) (P < 0.0001).

The study also demonstrated positive safety data, with the most common adverse event being diarrhea, occurring in 4.3% of the linaclotide group and 1.8% in the placebo group.

Reference:

AbbVie Submits Supplemental New Drug Application to U.S. FDA to Support New Indication of LINZESS (linaclotide) for Functional Constipation in Children and Adolescents 6 to 17 Years of Age. AbbVie. December 16, 2022. Accessed December 16, 2022. https://news.abbvie.com/news/press-releases/abbvie-submits-supplemental-new-drug-application-to-us-fda-to-support-new-indication-linzess-linaclotide-for-functional-constipation-in-children-and-adolescents-6-to-17-years-age.htm?view_id=5591