FDA Accepts Shire sNDA for Pediatric Short Bowel Syndrome

FDA has accepted for review a Shire supplemental NDA to expand 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 nutrition support. The drug is currently indicated for treating adult patients with SBS who are dependent on parenteral support. Those with SBS are unable to absorb enough nutrients and fluids from what they eat and drink alone. The agency is expected to determine a review action 3/2019.

The application included data from two Phase 3 studies as well as interim data from two ongoing extension studies. The company says data showed that 54.2% and 69.2% of patients treated with teduglutide (0.025 mg/kg and 0.05 mg/kg, respectively) vs. 11.1% receiving standard of care achieved a 20% or greater reduction in the volume of parenteral support at 24 weeks compared to baseline, the study’s primary efficacy endpoint.