IRWD - AbbVie Ironwood Linzess gets FDA priority review to treat functional constipation in children

• The U.S. Food and Drug Administration (FDA) granted priority review to AbbVie ( NYSE: ABBV ) and Ironwood Pharmaceuticals' ( NASDAQ: IRWD ) application seeking expanded approval of Linzess (linaclotide) to treat children and adolescents aged six years to 17 years with functional constipation (FC).
• The FDA accepted the company's supplemental Biologics License Application (sBLA) and is expected to make a decision by June 14.
• Under priority review, the FDA's goal is to take action within six months, compared to 10 months under standard review.
• The sNDA filing was backed by data from a phase 3 trial.
• "If approved, we look forward to a commercial launch mid-2023," said Ironwood CEO Tom McCourt.
• Linzess is developed and marketed by Ironwood and AbbVie in the U.S. and is currently approved to treat 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, the company noted.
• IRWD +1.16% to $11.30 premarket Feb. 13
• ABBV -0.36% to $151.50 premarket

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