FDA accepts sNDA for Gattex for pediatric patients with Short Bowel Syndrome.- Shire plc

Shire plc announced that the FDA has accepted for filing the supplemental new drug application to extend the indication of Gattex (teduglutide [rDNA origin]) for Injection to pediatric patients (aged 1-17 years old) with Short Bowel Syndrome (SBS) who are dependent on parenteral support. Gattex is a prescription medicine indicated for the treatment of adult patients with SBS who are dependent on parenteral support.

Shire submitted the supplemental new drug application to the FDA on September 11, 2018. The U.S. FDA is expected to reach a decision in March 2019.

SBS is a serious, chronic and rare malabsorption disorder resulting from surgical resection. People with SBS are unable to absorb enough nutrients and fluids from what they eat and drink alone. Malabsorption puts people at risk for diarrhea, dehydration, electrolyte disturbances and malnutrition. Children with SBS have had a large portion of the intestine removed by surgery due to congenital or acquired conditions of the newborn or trauma.

The application included data from two core, completed Phase III studies as well as interim data from two ongoing extension studies. The Phase III studies included a 24-week, double-blind , multi-center, multi-national trial (TED-C14-006) and a 12-week, open-label, multi-center study (TED-C13-003), both of which evaluated the efficacy, safety, and pharmacodynamics of Gattex in children with SBS who were stable on their required parenteral nutrition (PN)/ intravenous (IV) support that provided at least 30% of caloric and/or fluid/electrolyte needs for at least three months prior to screening..