FDA OKs Expanded Indication for Short Bowel Syndrome Treatment to Include Children

Officials with the FDA have approved extending the indication of Takeda Pharmaceuticals’ teduglutide (Gattex) for injection to pediatric patients age 1 year and older with Short Bowel Syndrome who need additional nutrition or fluids from intravenous feeding.

Officials with the FDA have approved extending the indication of Takeda Pharmaceuticals’ teduglutide (Gattex) for injection to pediatric patients age 1 year and older with Short Bowel Syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding, according to the drug manufacturer.

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 patient’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 Beth Carter, MD, Medical Director of Intestinal Rehabilitation and Nutrition Support, Children’s Hospital Los Angeles, in a prepared statement. “I’m pleased that patients have access to a medication that may help them reach that goal.”

According to Takeda, teduglutide is the first and only medicine that mimics naturally occurring glucagon-like peptide-2 (GLP-2). The recommended dosage of GATTEX for both adults and pediatric patients is 0.05 mg/kg once daily by subcutaneous injection. Use of the GATTEX 5 mg kit is not recommended in pediatric patients weighing less than 10 kg.

In a pharmacodynamic study in adults, teduglutide was shown to improve the amount of fluids absorbed by the intestines.

In a 24-week pediatric study, teduglutide helped reduce the volume of daily PS required and time spent administering PS. Some children achieved complete freedom from PS. Fifty- nine pediatric patients ages 1-17 years with SBS chose whether to receive teduglutide or standard of care (SOC). Patients who chose to receive teduglutide treatment were subsequently randomized in a double-blind manner to 0.025 mg/kg/day (n=24) or 0.05 mg/kg/day (n=26), while 9 patients enrolled in the SOC arm.

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