AbbVie Submits SNDA For Linaclotide For Treatment Of Children, Adolescents

AbbVie (ABBV) has submitted a supplemental New Drug Application for linaclotide or LINZESS to the FDA for the treatment of children and adolescents 6 to 17 years of age with functional constipation. The sNDA submission is based on results from a Phase 3 clinical trial. The company noted that, if approved, linaclotide would be the first prescription therapy for functional constipation in children and adolescents 6 to 17 years of age.

LINZESS is developed and marketed by AbbVie and Ironwood Pharmaceuticals in the United States. It is currently indicated for the treatment of adults with chronic idiopathic constipation or irritable bowel syndrome with constipation.

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