Boston-based Ironwood Pharmaceuticals’ blockbuster drug for gastrointestinal problems was cleared Monday to treat functional constipation in patients 6 to 17 years of age, making it the first approved medicine for the disorder in pediatric patients.
Linzess, which was approved by the Food and Drug Administration in 2012 to treat irritable bowel syndrome with constipation in adults, generated more than $1 billion in US net sales in each of the last two full years, according to a company spokesman.
“Today, Ironwood has broken new ground again in the history of Linzess,” said company chief executive Tom McCourt. “This approval is a momentous step forward in progressing our mission to advance the treatment of GI diseases and redefine the standard of care for GI patients and in ushering in a new era of growth for our company.”
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Functional constipation is a chronic condition in which a person has hard, infrequent bowel movements. The condition affects an estimated 6 million children and adolescents between the ages of 6 and 17.
Jonathan Saltzman can be reached at jonathan.saltzman@globe.com.