BRIEF—Takeda's Gattex approved in USA for children with SBS

17 May 2019

The US Food and Drug Administration has approved extending the indication of Japan pharma major Takeda’s Gattex (teduglutide) for injection to pediatric patients 1 year of age and older with short bowel syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding (parenteral support).

In children, SBS is a life-threatening, chronic, and rare malabsorption disorder resulting from surgical removal of a large portion of the intestine, which is typically due to congenital or acquired conditions of the newborn or trauma.

Children with SBS are unable to absorb enough nutrients and fluids from what they eat and drink alone.

A goal of SBS treatment is to restore the remaining intestine's ability to absorb nutrients and reduce long-term dependence on parenteral support (PS).

"As a pediatric gastroenterologist, one of my main treatment goals for children with SBS is to reduce their dependency on parenteral support," said Dr Beth Carter, medical director of Intestinal Rehabilitation and Nutrition Support, Children's Hospital Los Angeles.

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