Ironwood Pharma's Pediatric Functional Constipation Treatment Gets FDA Approval

(RTTNews) - Ironwood Pharmaceuticals, Inc. (IRWD), Monday announced that the U.S. Food and Drug Administration 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 supplemental New Drug Application, 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.