FDA nod for first pediatric functional constipation treatment

13 June 2023

The US Food and Drug Administration (FDA) late yesterday said it has approved Linzess (linaclotide) capsules to treat functional constipation in pediatric patients aged six to 17 years.

This is the first treatment for this indication and brings a much-needed option to an estimated 6 million 6-17-year-olds in the USA affected by this chronic, prevalent condition.

Linzess is developed and marketed by US gastrointestinal (GI)-focused firm Ironwood Pharmaceuticals (Nasdaq: IRWD), whose shares were up 3.7% at $11.84 in pre-market activity today, and its partner AbbVie (NYSE: ABBV) in the USA. The drug has been available since 2012 for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). Linzess has already reached blockbuster status in IBS, bringing in more than $1 billion in net sales in 2022.

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