Posted by Michael Wonder on 17 Dec 2022
AbbVie submits supplemental new drug application to US FDA to support new indication of Linzess (linaclotide) for functional constipation in children and adolescents 6 to 17 years of age
16 December 2022 - Submission is based on positive Phase 3 study data demonstrating linaclotide (72 mcg) resulted in increases in frequency of spontaneous bowel movements and improved stool consistency in children and adolescents aged 6 to 17 years.
AbbVie today announced that it has submitted a supplemental new drug application for linaclotide (Linzess) to the US FDA for the treatment of children and adolescents 6 to 17 years of age with functional constipation.
