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Ironwood Pharmaceuticals Announces FDA Filing Acceptance and Priority Review of Supplemental New Drug Application for LINZESS® (linaclotide) for Functional Constipation in Children and Adolescents Ages 6-17 Years-Old
– FDA assigns 2nd Quarter 2023 target action date – – If approved, LINZESS would be the first and only FDA-approved prescription therapy for functional
About this update from Ironwood Pharmaceuticals, Inc.
[{"type":"text","content":"\n– FDA assigns 2nd Quarter 2023 target action date –\n\n– If approved, LINZESS would be the first and only FDA-approved prescription therapy for functional constipation in this patient population –\n\n– Functional constipation affects an estimated 6 million 6-17 year-olds in the U.S.1 –\n\n BOSTON--(BUSINESS WIRE)--\nIronwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental New Drug Application (sNDA) for LINZESS® (linaclotide) for the treatment of children and adolescents ages 6-17 years-old with functional constipation (FC). The FDA has assigned the application a Prescription Drug User Fee Act (PDUFA) date of June 14th, 2023, four months earlier than the standard review cycle.\n\nThe FDA grants priority review to therapies that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions and to pediatric supplements submitted pursuant to the Best Pharmaceuticals for Children Act.2\n\n“Pediatric functional constipation has a significant impact on young patients and their families, yet there are no FDA-approved prescription therapies available for this population,” said Michael Shetzline, M.D., Ph.D., chief medical officer, senior vice president and head of research and drug development at Ironwood Pharmaceuticals. “We welcome the FDA’s decision to grant priority review, as it brings us even closer to potentially changing the treatment landscape for pediatric patients ages 6-17 years-old with this condition.”\n\nFC in children is defined as a chronic condition with hard, infrequent bowel movements that are often difficult or painful to pass3. The condition affects an estimated 6 million children aged 6-17 years-old in the U.S.1\n\n“As a company focused on advancing the treatment of GI diseases, we have worked with a sense of urgency to expand the clinical utility of linaclotide to this underserved pediatric population with FC,” said Tom McCourt, chief executive officer of Ironwood Pharmaceuticals. “If approved, we look forward to a commercial launch mid-2023.”\n\nThe sNDA filing was based on the results of a large, multicenter, double-blind, Phase III study evaluating linaclotide in patients ages 6-17 years-old with functional constipati...