AbbVie submits sNDA to FDA for linaclotide

AbbVie announced that it has submitted a supplemental New Drug Application for linaclotide to the U.S. 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, which met the primary and secondary endpoints, evaluating linaclotide for increased frequency of spontaneous bowel movements and improvement in stool consistency in patients aged 6 to17 years. LINZESS is developed and marketed by AbbVie and Ironwood Pharmaceuticals in the United States and is currently indicated for the treatment of adults with chronic idiopathic constipation or irritable bowel syndrome with constipation.