Submission of sNDA to FDA to support new indication of Linzess for functional constipation in children and adolescents 6 to 17 years of age.- Abbvie + Ironwood Pharma
AbbVie announced that it has submitted a supplemental New Drug Application (sNDA) for linaclotide (Linzess) to the FDA for the treatment of children and adolescents 6 to 17 years of age with functional constipation (FC).
The sNDA submission is based on results from a Phase III clinical trial, which met the primary and secondary endpoints, evaluating linaclotide (72 mcg) for increased frequency of spontaneous bowel movements (SBM) and improvement in stool consistency in patients aged 6 to 17 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 (CIC) or irritable bowel syndrome with constipation (IBS-C).
"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 multicenter double-blind Phase III study evaluating Linzess in patients 6 to 17 years of age with functional constipation, a total of 330 patients were randomized in a 1:1 ratio between linaclotide or placebo. Linaclotide showed a statistically significant and clinically meaningful improvement compared to placebo in 12-week SBM frequency rate (SBMs/week), the primary endpoint. Linaclotide-treated patients demonstrated a greater than two-fold least squares mean change from baseline in SBMs/week (2.220) compared to placebo (1.050) (p<0.0001).></0.0001).>
The Phase III study demonstrated acceptable safety in the pediatric population. The most common adverse event in the pediatric Phase III study was diarrhea which occurred in 4.3% of linaclotide-treated patients versus 1.8% in the placebo group. FC in children is defined as a condition with hard, infrequent bowel movements that are often difficult or painful to pass. FC is a common problem in children of all ages, with a worldwide prevalence ranging between 0.7% and 29.6%. Core symptoms of FC include decreased stool frequency, harder stool consistency, painful passage of stools, and fecal incontinence.
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