IRWD & ABBV receiving prioorty FDA review of LINZESS

– If approved, LINZESS would be the first and only FDA-approved prescription therapy for functional constipation in this patient population –
– Functional constipation affects an estimated 6 million 6-17 year-olds in the U.S.1 –

BOSTON, February 13, 2023--(BUSINESS WIRE)--Ironwood 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.
LINZESS is developed and marketed by Ironwood and AbbVie (ABBV) in the United States and is currently indicated for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). It is not approved for use in patients less than 18 years of age.