Ironwood announces FDA approval of new indication for Linzess

Ironwood Pharmaceuticals (IRWD) announced that the U.S. Food and Drug Administration has approved LINZESS 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, 4 months earlier than the standard review timeline. LINZESS is developed and marketed by AbbVie (ABBV) and Ironwood Pharmaceuticals in the United States. “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.”