– LINZESS is the first and only FDA-approved prescription therapy for functional constipation in this patient population –
– Approval brings a much-needed option to an estimated 6 million 6-17-year-olds in the U.S.1 affected by this chronic, prevalent condition –
BOSTON--(BUSINESS WIRE)-- Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has approved LINZESS® (linaclotide) as a once-daily treatment for pediatric patients ages 6-17 years-old with functional constipation. LINZESS is the first and only FDA-approved prescription therapy for functional constipation in this patient population. Earlier this year, the FDA granted a 6-month priority review to our supplemental New Drug Application (sNDA), 4 months earlier than the standard review timeline. LINZESS is developed and marketed by AbbVie and Ironwood Pharmaceuticals in the United States.
Functional constipation in children is a chronic condition characterized by hard, infrequent bowel movements that are often difficult or painful to pass2. The condition affects an estimated 6 million children ages 6-17 years-old in the U.S.1
“When you have a child with functional constipation, it is extremely hard to watch them suffer – spending hours in the bathroom and away from their friends – while there is little you can do as a parent to help them,” said Ceciel T. Rooker, President, International Foundation for Gastrointestinal Disorders. “There has long been a critical need for a new therapeutic option due to lack of approved prescription treatment options, so I’m thrilled that we now have a new prescription option for children that can effectively help address symptoms.”
The FDA approval was based on the results of a large, multicenter, double-blind, Phase III study evaluating LINZESS in patients ages 6-17 years-old with functional constipation. A total of 328 patients received the study treatment, randomized in a 1:1 ratio between LINZESS 72 mcg or placebo. In this pivotal study, linaclotide showed a statistically significant and clinically meaningful improvement compared to placebo in 12-week spontaneous bowel movement (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 (2.6) compared to placebo (1.3) (p