The U.S. Food and Drug Administration on Wednesday approved Linzess (linaclotide), developed by Ironwood Pharmaceuticals (IRWD) and AbbVie (ABBV), for children with irritable bowel syndrome with constipation (IBS-C), expanding its label further. Shares of Ironwood (IRWD) climbed ~17% after the FDA announced the decision.
The once-daily capsule was previously approved in the U.S. for adults with IBS-C or chronic idiopathic constipation.
As per the new label, it will also be indicated for children seven years and older with IBS-C, marking the first U.S. treatment option for pediatric patients with the condition.
In August, Ironwood (IRWD) set its full-year net sales outlook for Linzess at $800M – $850M. Late October, shares of the Boston, Massachusetts-based biotech surged after AbbVie (ABBV) reported $315M in U.S. sales for Linzess, implying ~40% YoY growth and well exceeding the consensus estimates.